69 Pharmaceutical jobs in Ireland

**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs around 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford, Kilkenny and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Ireland Nutrition Division Cootehill Cavan**
Abbott Nutrition produces a range of infant formulae in all pack sizes under the brand name "Similac". To complement the range of "Similac" infant formulae, the facility also manufactures a range of follow on formulae under the brand name of "Gain". The essential ingredient is liquid skim milk and this is combined with carbohydrate, vegetable oils, vitamins and minerals. The product is blended, pasteurised, dried and packaged at the site and once packaged, is distributed to Europe, South East Asia, the Middle East, Latin America and Canada.
Established in 1975, Abbott Nutrition in Ireland is the largest powder manufacturing facility for the production of infant formulae within the Abbott Corporation worldwide. Approximately 1,000 dairy farms in Ireland and Northern Ireland supply quality milk to the Cootehill facility which processes 500,000 litres per day. This secure supply together with Ireland's reputation as a green, clean environment is of significant strategic importance to Abbott Nutrition.
**Primary Function / Goals / Objectives**
+ The CAPA Specialist will report to the CAPA & Validation Manager.
+ Conduct weekly or more frequent CAPA meetings to track timelines and quality of Quality Records (QRs) and associated actions.
+ Provide Leadership and support on the Corrective and Preventative Action System to all plant personnel.
+ Report on monthly metrics with regard to CAPA and QRs.
+ Ensure that all appropriate site Quality CAPA metrics are recorded and verified.
+ Provide training to site subject matter experts and plant with regard to CAPA requirements as guided by division/corporate where required.
+ Review site QRs to ensure compliance to Rubric requirements and associated site and division policy requirements.
+ Collate CAPA information for site management review and area tier 3 information.
+ Provide guidance in management of unexpected manufacturing events, required bracketing and containment and associated sampling if required.
+ Complete Global CAPA review for impact to Cootehill site and support elevation process for site issues as required post QR approval.
+ Support the QA CAPA IT System (ABTRAQ) through which investigations and CAPA's are documented. This also involves the development and support of plant SME's and general users.
+ Liaise with other plant CAPA Specialists in Community of Practice meetings to address global concerns on CAPA opportunities/systems.
+ Food Safety Team member - actively participating in Food Safety Team meetings, as required.
+ Participate in internal audits and compliance walkdowns.
+ Complete related projects as required.
+ This Job function will change where updates to procedures to GMP, EHS, Technical / New Equipment, Quality Procedures & SOP's are made.
+ This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible where this need arises.
+ Support QA team in other responsibilities/projects as required and when the need arises.
+ Support QA team with internal and external audits (including pre-audit preparation) surrounding the CAPA Process.
+ Follow all Environmental, Health and Safety Rules and Regulations in the plant.
+ Report any current or potential hazards to your manager immediately.
+ Wear the correct Personal Protective Equipment (P.P.E.) at all times. Consult the appropriate SOP where required.
+ This function has the responsibility for reviewing all SOP's for any job task he/she may carry out and ensure he/she fully understands and adheres to the SOP.
**Major Responsibilities**
+ The CAPA Specialist will review all Quality Records (QRs). Will provide leadership and direction for QR initiation and root cause analysis.
+ The CAPA Specialist shall ensure that site Quality CAPA Metrics are recorded and reported as needed.
**Education Required**
+ A Diploma/Degree level education - science/engineering qualification an advantage.
**Knowledge**
+ At least three years manufacturing experience in a quality assurance function within a regulated environment.
+ Excellent interpersonal skills and very good computer literacy.
+ Ability to work as an effective member of a high performance team.
**Accountability / Scope**
+ This function will have the responsibility to ensure that Quality Records (QRs) are completed and that leadership and direction for QR initiation and root cause are complete. Will ensure that monthly Metrics are recorded and reported out as required. The impact of ineffective reporting may have implications on plant operations and compliance requirements.
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An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

**Job Title: Associate Director, Pharma Business Operations**
Job Requisition Number: 2308263
Location: Dublin and/or Letterkenny
Workplace / Work Arrangement: Hybrid
Job Type: Full-time
Business Segment: Optum
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**About the Role**
We are looking for an experienced, curious and self-motivated individual who will be responsible for identifying and developing net new business opportunities intended to deliver enhanced financial and operational performance. The successful candidate will report to the VP of Industry Relations, Emisar. We are looking for people who can collaborate cross-functionally with various business and data analytics teams, demonstrate exceptional attention to detail, lead and develop teams, have proven business development experience, and the ability to manage multiple competing business projects at one time.
**About the Team**
Emisar is a Group Purchasing Organisation within the overall Optum structure, working closely with manufacturers to negotiate value on pharmaceutical products for the benefit of our member._
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**What You'll Do:**
* Develop and implement pharmaceutical tracking that inform Emisar Industry Relations leads to key opportunities to drive Emisar initiatives and standardization
* Review and monitor pharmaceutical contract deviations to inform standardization
* Help establish objectives, define deliverables, structure work effort, and mobilize cross-functional teams to deliver against Emisar initiatives
* Actively seeks to improve current processes and coordinate organizational procedures for optimized efficiency
* Manage the analysis of industry trends, competitive risks, client and consumer needs, expansion opportunities and internal performance
* Help drive development of market and competitive intelligence to support business planning and strategy development efforts
* Support pipeline development of high-ROI, high-growth opportunities
* Help evaluate new opportunities, including assessment of opportunity size, capabilities and gaps, cost and risk to develop, and buy/build/partner analysis
* Inform the development and evolution of processes to monitor invoicing of Emisar initiatives
**What You'll Bring**
**Required Qualifications & Experience:**
* Undergraduate degree or equivalent
* Understanding of competitive landscape and familiarity with pharmaceuticals or healthcare industry
* Proven ability to work collaboratively across a matrix environment to deliver business goals
* Experience in working with and analyzing diverse datasets to develop business insight and strategy
* Proven ability to develop and lead business projects with accountability of work to senior management level stakeholders
* Excellent verbal and written communication skills. Ability to speak clearly and concisely, conveying complex or technical information in a manner that others can understand, as well as ability to understand and interpret complex information
If you don't meet every single requirement, don't let that hold you back-we're just as
excited about potential as we are about qualifications and experience, and you could be
exactly who we're looking for.
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**About Us**
UnitedHealth Group is a Fortune 10 global health care leader committed to helping people live healthier lives and improving the health care system for everyone. The organization operates through two complementary businesses (learn more about UnitedHealth Group ( ):
* UnitedHealthcare, which offers health benefits and insurance services (learn more about UnitedHealthcare ( )
* Optum, which provides care delivery, technology, and data-driven health solutions (learn more about Optum ( )
Optum Services (Ireland) Ltd, with offices in Dublin and Letterkenny, serves as a strategic innovation and technology hub, driving transformation in health care through advanced analytics, software engineering, and clinical expertise (learn more about Optum Ireland ( ).
Join us to start Caring. Connecting. Growing together.
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**What We Offer**
* Opportunities for professional development
* Inclusive and supportive team culture
* (Other benefits: e.g., health insurance, wellness programs, etc.)
___
**How to Apply**
Click "Apply" and submit your CV or LinkedIn profile. If you need any accommodations during the application process, please let us know - we're here to help.
**Interview Process**
Should you application be shortlisted the process will be as follows:
* Recruiter Call (within 10 working days of application)
* Initial Call from Hiring Manager
* Technical assessment
* Final Interview
o Technical Interview
o Business Fit/Meet the Team
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**Please note you must currently be eligible to work and remain indefinitely without any restrictions in the country to which you are making an application. Proof will be required to support your application.**
All telecommuters will be required to adhere to the UnitedHealth Group's Telecommuter Policy.
At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalised groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.
Diversity creates a healthier atmosphere: Optum is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, civil status, family status, sexual orientation, disability, religion, age, race, and membership of the Traveller community, or any other characteristic protected by law. Optum is a drug-free workplace. © 2025 Optum Services (Ireland) Limited. All rights reserved.
#BBMEMEA

**Regulatory Affairs Manager- candidate can come from Quality or Regulatory background.**
**This is a permanent role with full Stryker benefits- bonus, pension and healthcare for employee and their family.**
**Key Areas of Responsibility:**
+ Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
+ Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
+ Provides guidance to integrate regulatory considerations into global product entry and exit strategy
+ Identifies regulatory pathways for initial product designs and provides input to internal stakeholders
+ Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes
+ Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
+ Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
+ Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)
+ Negotiates with regulatory authorities on complex issues throughout the product lifecycle
+ Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
+ Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
+ Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
+ Provides strategic input and technical guidance on global regulatory requirements to product development terms
+ Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
+ Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
+ Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
+ Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases
+ Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships
+ Provides regulatory guidance on strategy for proposed product claims/labeling
+ Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
+ Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions
+ Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process
+ Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees
**Education / Work Experience:**
+ BS in a science, engineering or related Advanced degree preferred
+ Minimum of 8 years experience
+ People Management experience required
#IJ
#INDEMEA
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**QC Chemist**
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
**The Position**
QC Chemist in QC Commercial group supporting Bioanalyticalanalytical testing supporting testing plans across multiple products. This is a pivotal role in terms of execution and delivery for the business and supporting test and release of priority lots. The role supports activities related to structured problem solving, technical support for laboratory investigations and support teams such as safety, 5S, Good lab practices and training.
**Job duties include:**
+ Supports testing of finished product across a variety of techniques for the solid oral dosage, sterile and biologic product portfolio.
+ Review of analytical data and documentation to ensure compliance to appropriate specifications and protocols.
+ Supports reviews and investigations for out- of trends/out-of specifications.
+ Participates in validation and commercial/developmental manufacturing activities
+ Troubleshoots standard instrumentation/test methods.
+ Coordinates waste management, LEAN/Operational excellence and 5S efforts as required.
+ Participate in QC and cross-functional projects as required.
+ Assists in the training of QC staff.
+ Writes and revises methods, specifications, and SOP's as needed.
**Knowledge, Experience and Skills:**
+ Chromatographic separations experience in UPLC/HPLC and Empower
+ Technical writing (protocols, reports, procedures)
+ The ability to analyse data with a logical approach to problem solving and troubleshooting
+ Excellent spoken and written communication skills
+ Proficient in Microsoft office
+ Working knowledge of GMPs, GLPs, pharmacopoeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.
**Education & Experience**
+ BSc degree in analytical Biochemistry or equivalent.
+ Prior experience in pharmaceutical industry is preferred
**Behaviours**
+ Resilient profile with the ability to deliver in an ambiguous environment
+ Ability to engage and manage multiple stakeholders to achieve the objective
+ Curious with learning agility
+ Operationally excellent
+ Organised with systematic approach to prioritisation
+ Process orientated to achieve the business objective
**Gilead Core Values**
+ Integrity (always doing the right thing),Teamwork (collaborating in good faith),
+ Excellence (working at a high level of commitment and capability)
+ Accountability (taking personal responsibility).
+ Inclusion (Encouraging Diversity)
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

This is a 12 month contract with full Stryker benefits.
**What you will do:**
+ Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a technical and/or tactical nature
+ Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
+ Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
+ Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
+ Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
+ Evaluates proposed products for regulatory classification and jurisdiction
+ Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
+ Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
+ Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
+ Negotiates with regulatory authorities throughout the product lifecycle
+ Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
+ Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
+ Assists other departments in the development of SOPs to ensure regulatory compliance
+ Provides regulatory input and technical guidance on global regulatory requirements to product development teams
+ Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
+ Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
+ Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
+ Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
+ Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
+ Provides regulatory information and guidance for proposed product claims/labeling
+ Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
+ Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
+ Monitors the progress of the regulatory authority review process through appropriate communications with the agency
+ Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
+ Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
**What you will need:**
+ BS in Engineering, Science, or related degree; or MS in Regulatory Science
+ Typically a minimum of 4 years' experience
#IJ
This role will be posted for a minimum of 3 days.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

**Job Family:** Buildings
**Req ID:** 467188
Together with our customers, we combine the real and digital worlds With technology, software and services for smart buildings, we transform the everyday for everyone. By combining the real and digital worlds, we empower our customers to reach their decarbonization goals, lower their operating costs and create world-class occupant experiences for their people. It's not just about improving buildings - it's about creating efficient, safe, adaptable and sustainable environments, which improve the way the world lives and works. The digital transformation of buildings is a fast-changing, dynamic sector, and it needs more than just great technology - it needs great people, too. We know a business only thrives if its people are thriving, so at Siemens we put our people first. We are looking for a new colleague with a comprehensive understanding of overall data center solutions to join our Global Datacenter Application Hub. In this role, you will support external consultants and planners in designing tailored specifications for data centers in the field of liquid cooling, simulations, automation, security, fire and power monitoring. You will develop a standard reference prescription to position Siemens as the trusted advisor for data center solutions. You will collaborate with cross-Business Unit professionals, partners and the sales teams in our focus countries to drive specifications and promote our portfolio. Within our buildings business, our distributed team will support you through your career and challenge you to grow in new and exciting ways, as we transform the world's infrastructure. Our shared journey could take you anywhere . where would you like to go? Your new responsibilities Identify and engage with existing and potential partners and customers, understanding their needs to bring value propositions that differentiate Siemens in the data center market Collaborate with consultants in the data center market to specify Siemens products and solutions, ensuring alignment with industry standards and client requirements Partner with cross-BU Siemens sales teams to drive specifications and promote products, solutions, and services to customers in the data center vertical Engage with business decision-makers at all organizational levels to identify requirements and new market opportunities Monitor industry trends and competitors' activities to develop standardized design and identify innovation opportunities Work closely with marketing refine Siemens' value proposition for consultants and technical decision-makers Deliver internal training sessions, visit client sites, and consistently exceed KPIs based on sales and engagement metrics Provide strategic insights to management regarding industry trends, regulatory changes, and competitive positioning to continuously improve Siemens' data center designs and offerings Your skills and experience Bachelor's degree in engineering or an equivalent; an MBA or relevant graduate degree is beneficial Proven experience in technical sales or vertical markets, with a strong focus on data centers In-depth understanding of data center technologies and solutions, including Integrated Data Center Management Suite, liquid cooling systems, and Data Center Infrastructure Management (DCIM) software Broad knowledge of regulatory, legislative, business, and technology trends across multiple markets Knowledge of medium voltage products and systems, protection systems, and energy automation solutions Excellent planning, communication, writing, and facilitation skills Ability to quickly adjust strategies and approaches as conditions change Possesses a rigorous and analytical attitude to overcome challenges and solve problems effectively Excellent communication and presentation abilities in English. German and any additional European language would be beneficial Location: qualified candidates need a valid work permit for the respective country. Relocation to another country is not planned Employee benefits: local benefits applyWhat it's like working for us We place significant emphasis on fostering an inclusive and flexible working culture that encourages everyone to be their authentic selves. Equal opportunities and diversity are important to us and contribute to an enriching culture. We actively embrace mobile working to provide every colleague with more autonomy and the chance to achieve a good work-life balance. Learn more here ( Frequently asked questions and contact information Here ( you will find a collection of frequently asked questions and a way to contact us directly. Information for recruitment agencies: Siemens is not accepting applications from recruitment agencies for this position. Thank you for your understanding.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
PCI JOB DESCRIPTION Job Title: JD-066
Qualified Person (Hybrid - 3rd Party Products) Department:
Quality Division / Section:
Clinical Services Accountable to:
Associate Director of Quality Accountable for: (People Manager)
Yes - includes managerial support to QA specialists
Responsibilities
Overall Quality Responsibilities
The Qualified Person is responsible for certifying investigational medicinal products in accordance with requirements of Investigational Medicinal Product Dossier (IMPD), Product specification File (PSF).
-The compliance of all batches to EU Directives, Annex 16 and Detailed Commission Guidelines where applicable for Investigational Medicinal Products (IMPs).
-Provide the Quality management team direct support and guidance in all quality matters to ensure that Quality operations meet the required site safety, quality, and cGMP requirements.
-Participate in cross functional teams to provide consultative support on quality related issues.
-Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs).
-During review, the QP ensures that all regulatory requirements are met regarding importation, testing and the release of clinical product to third party sites.
-Completion of QP Declarations to declare product manufactured in accordance with both trial-specific processes as well as EU GMP standards.
-Complete the QP review/disposition of Drug Substance/ Drug Product and Finished Pack product of Biologics, Steriles, ATMP's, across a range of dosage forms e.g Parenteral, Topical, Inhalational, Rectal, Opthalmic.
Quality Operations
-Review batch documentation to ensure that the entire process has been performed in accordance with relevant product specification file (PSF), and cGMP/cGCP, and that it meets customer and agency audit standards.
-Review of clinical Batch records, including control reports, in-process test reports and release reports demonstrating compliance with the product specification file, the order, protocol, and randomization code
-Disposition (back to customer QPs or clinical trial site) and certify completed batches efficiently.
-Achieve "right first time" objectives, tracking quality and efficiency standards.
-By direct observation and intervention, monitor the application of quality standards to enable quality processes, compliant documentation, timely corrective action and continuous improvement.
Quality Systems
-Provide support with investigations and resolution of discrepancies within deviations. Participating in cross functional teams as Quality/Qualified Person representative
-Lead or provide CAPA recommendations.
-Support to change control impact assessments and completion.
-Communicating with contract manufacturers to resolve compliance issues in clinical and commercial supply chains, interfacing with customer/partner quality organizations, and
-Completion of third-party contractor and supplier quality agreements and supply chain documents.
-Provide audit support as required for client Health Authority Inspections, internal auditing, supplier audits. Ensuring any observations are adequately and promptly addressed.
-Provide experienced support to Customer complaints and deviations and join cross functional resolution initiative.
Quality Projects and Continuous Quality Improvement
-Provide support to direct QA reports, in development, progress and feedback.
-Give quality direction and guidance for projects related to processes, product and compliance
-Compile new and update existing technical agreements.
-Support the Quality team in implementation of new product introductions.
-Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice
-Develop and sustain an environment of continuous improvement through active implementation of process excellence and lean six-sigma methodologies.
-Actively promote best practice in quality methods and drive continuous improvement initiatives to improve quality, cost and cycle times.
-Develop training programs and support in training rollout.
General
-Collaboration across the organisation and act as SME/team representation on required meetings.
-Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice. Research, analyse and extrapolate critical regulatory information
-Knowledge of 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for medicinal products for human and veterinary use and the Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014
-Knowledge on quality systems regulations, QA principles and industry best practices and standards and utilize in day-to-day activities.
Secondary Responsibilities
-Provide supervisory support to QA specialists and complete review and feedback on batch record review. Support in mentorship capacity.
-Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
REQUIREMENTS
-Bachelor's degree in science, engineering, technology or a related discipline.
-Qualified Person status or eligibility for QP status. Clinical Experience desirable but not essential.
-At least 3-5 years' experience in a quality management role in the Pharma industry.
-Sound industry knowledge of the requirements of EU GMP, steriles experience is desirable.
-Extensive quality systems and quality operations experience.
-Strong organisational / time management skills. Effective interpersonal communications, leadership and excellent decision making skills.
-Experience of working at management level within a similar environment.
-High motivation, flexibility and the ability to work under pressure and on own initiative.
All employees are required to satisfactorily perform the essential duties and responsibilities of their position. The essential duties and responsibilities listed above are not intended to be an exhaustive list of all responsibilities, duties and skills required.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Supervisor - GMP Pharma lab, Athlone**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
We have an opportunity within our Analytical GMP labs facility and analytical testing on drug substances and products. This role is based at our site in Athlone, Ireland.
**Discover Impactful Work:**
Provides line-level management coordination of resources and work schedules. Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Ensures that projects are completed in a timely manner so that company revenues are met, and clients are satisfied with the quality and turnaround time of work being performed. Ensures that staff continue to be developed to keep pace with department goals and growth.
**A day in the Life:**
+ Supervises the daily activities of analysts within the Pharmaceutical team, including interviewing, selection, hiring, professional development, performance management, and reviews and approves time records, requests for leave, and overtime.
+ Manages daily workflow, allocates resources, and tracks performance metrics.
+ Identifies and recommends process improvements and efficiency gains to optimize processes.
+ Monitors and ensures compliance with quality standards, investigates and resolves complex problems through root cause analysis, and implements corrective actions.
+ Responds to facility audit findings.
+ Assists management in their responsibilities.
+ Assists in preparation and implementation of PPD/client SOPs and company operational policies. Ensures adherence to SOPs, safety standards and company policies
**Keys to Success:**
**Education**
Bachelor's degree or equivalent preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.
**Experience**
+ 1+ year demonstrated leadership qualities preferred
+ 5+ years experience in analytical GMP laboratory
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills, Abilities**
+ Demonstrated proficiency of good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging deadlines.
+ Proven leadership skills of technical staff
+ Ability to train and mentor junior staff
+ Demonstrated ability to be project solution driven
+ Good written and oral communication skills as well as presentation skills
+ Can independently perform root cause analysis
+ Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.)
+ Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs
+ Project and time management skills
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. A one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability** **Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1- *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
+ This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response
**_We welcome and encourage applicants from outside of Ireland. We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant._**
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive
impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
**Discover Impactful Work:**
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. May use local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. May act as a buddy during onboarding phase and provide training to new staff as needed.
**A day in the Life:**
- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
- Ensures allocated tasks are performed on time, within budget and to a high- quality standard. Proactively communicates any risks to project leads.
- Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
- Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Assists with coordination, compilation and distribution of Investigator Site File
(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
- Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
- Where applicable, conducts on-site feasibility visits (APAC only).
- May support scheduling of client and/or internal meetings.
- May review and track of local regulatory documents.
- May provide system support (i.e., Activate & eTMF).
- May support RBM activities.
- May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and activity plans in appropriate system(s).
- Transmits documents to client and centralized IRB/IEC.
- Maintains vendor trackers.
- Supports start-up team in Regulatory submissions.
- Works directly with sites to obtain documents related to site selection.
- Assists the project team with the preparation of regulatory compliance review packages.
- Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.
- May complete the 'Site Interest Plan' in CTMS and collection and delivery of
associated documents from investigators and site personnel.
- Documents in real time all communication, attempts a follow up associated with site contact and survey responses.
- Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
- Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
- Ensures an efficient, effective plan is in place for site contact and follow up.
Ensure compliance with the plan and escalate concerns/non-compliance to management.
- May act as the local expert regarding site capacity and experience.
- Work with key local personnel to gather knowledge base and recommend additional sites.
- Harness this knowledge base when performing local tiering of sites.
- Liaises with Global Investigator Services to resolve investigator queries in real
time and maintain 'accounts and contact' information.
- Contributes to the development and roll-out of global strategic feasibility processes and best practices.
- Trains new personnel in processes and systems.
- Utilizes local knowledge to contribute to the identification and development of new sites.
**Keys to Success:**
**Education**
- High / Secondary school diploma or equivalent and relevant formal academic /vocational qualification. Bachelor's degree preferred.
**Experience**
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills, Abilities**
- Ability to work in a team or independently as required
- Good organizational skills and strong attention to detail, with shown ability to handle multiple tasks efficiently and effectively
- Shown ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Flexibility to reprioritize workload to meet changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and
organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
- Good English language and grammar skills and proficient local language skills as needed
- Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
- Ability to successfully complete the organizations clinical training program
- Self-motivated, positive attitude and good social skills
- Effective oral and written communication skills
- Good social skills
- Essential judgment and decision-making skills
- Capable of accurately following project work instructions
- Good negotiation skills
- Independent thinker
- Ability to lead risk and perform risk escalation appropriately
**Working Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1- *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.