8 Pharmaceutical jobs in Ireland

Regulatory Affairs Specialist - 12 month FTC -Maternity Cover

Danaher Corporation

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Wondering what's within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Regulatory Affairs Specialist for Beckman Coulter Diagnostics is responsible for ensuring that the quality systems aspects such as CAPA management, global procedure review and participation in the cross-site Global Regulatory Affairs initiatives in addition to product registration, IVDR document maintenance and minor/moderate design change management for the AU Chemistry Product line.
This position is part of the Quality and Regulatory Affairs Department located in Beckman Coulter Ireland Inc., Lismeehan, O'Callaghan's Mills, Co. Clare, Ireland and is an on-site position. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the Regulatory Affairs team and report to the Senior Regulatory Affairs Manager, be responsible for providing regulatory support to local regulatory team on site, Beckman Coulter customers and Beckman Coulter's commercial regulatory teams globally. If you thrive in a fast paced, challenging and supporting role in a company that is focused on sustainability and want to work to build a world-class Quality and Regulatory Affairs organization-read on.
This role is eligible for flexible work arrangements
In this role, you will have the opportunity to:
+ Prepare and maintain technical files in compliance with IVD Directive and IVD regulation as applicable for the EU.
+ Act as RA representative on Design Change projects which includes the development and implementation of registration strategies for new product launches.
+ Review, preparation and compilation of documentation required for global regulatory submissions.
+ Support change management and perform RA support for minor and moderate design changes for the AU product line.
+ Support Global RA tasks/projects, which may include supporting RA colleagues outside of the Co. Clare site
+ Control distribution of product from regulatory perspective through regulatory stop ship program.
+ Be able to work in a busy environment
The essential requirements of the job include:
+ Qualified to a minimum of B.Sc. Level in a Science related field with a minimum of 3 years' experience in a QA or RA role within a manufacturing facility.
+ Excellent written and communication skills
It would be a plus if you also possess previous experience in:
+ Manage change effectively in order to better serve internal customers, external customers and legislative demands, in a busy environment, with demonstrated ability to multi-task
+ Understanding of the ISO13485, ISO9001, CMDR, MDLW, ANVISA, TGA, IVDD, IVDR and FDA (including China) regulation requirements.
At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
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Staff Specialist, Regulatory Affairs

Cork, Munster Stryker

Posted 12 days ago

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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
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.
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Quality Technical Product Manager, Pharmaceutical Diagnostics

Cork, Munster GE HealthCare

Posted 12 days ago

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**Job Description Summary**
Are you ready to make a significant impact in the world of Pharmaceutical Diagnostics (PDx). Join our dynamic IT team as a Quality Technical Product Manager!
In this pivotal role, you will collaborate closely with our Quality colleagues to shape strategic digitization priorities, develop a robust portfolio of investments, and create compelling business cases. Your expertise will be crucial in crafting detailed business requirements for approved investments and overseeing the delivery of key projects and products, including LIMS, Chromatography systems, Environmental Monitoring system, Quality Management system. This role ensures that all Quality IT systems are compliant with regulatory guidelines and drive continuous improvement in Quality processes.
You will help implement technology solutions in a cost-effective way by determining the requirements of a project or program, in alignment with strategic roadmap that helps achieve business objectives.
**Job Description**
**Responsibilities**
+ Implement, and maintain IT systems and software for the Quality department to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH).
+ Manage the investigation and resolution of IT-related issues, including system non-conformances and deviations. Lead investigation and troubleshooting on critical Lab application issues, and coordinate with different teams to get desired results.
+ Adept at requirements gathering & analysis through leading business process review sessions and stakeholder interviews.
+ Translate unstructured or ambiguous requests into actionable requirements through problem decomposition and planning.
+ Ability to map As-Is process based on inputs from business SME's and help establish the future process state
+ Prioritize continuously in accordance with the understanding and validation of customer problems and needs.
+ Stay updated with industry trends and regulatory changes to ensure compliance and best practices.
+ Lead the implementation of new IT technologies and methodologies to enhance QC efficiency and accuracy.
+ Own the short-term product roadmap and its integration into a larger application or strategic roadmap.
+ Strong written and verbal communication skills.
+ Function as communication hub for business to collate requirements and coordinate & drive deliverables.
+ Demonstrates strong analytical and creative problem solving and prioritisation skills
+ Demonstrate practical experience in Business Analysis methodologies to run meetings & stand-ups, relevant project documentation, and change controls to collaborate with all stakeholders.
**Qualifications and Requirements**
+ A Bachelor's Degree in Computer Science or "STEM" Majors (Science, Technology, Engineering and Math) or equivalent
+ Strong relevant professional experience in working in the Pharma or IT Industry including experience in the Digital Lab domain
+ Technical experience with Quality platforms such as, but not limited to - LIMS (Lab Information Management System), Chromatography systems (Chromeleon, Empower) , Environmental Monitoring, Quality Management systems is Mandatory.
+ Expert understanding of analysis & design and system architecture concepts.
+ Expert knowledge of CSV lifecycle with understanding of GxP (GLP/GCP/GMP), 21CFR Part 11, EU Annex 11.
+ Ability to execute in a technical environment and willingness to engage and understand technical solutions, challenges and issues.
+ Expert understanding of the Lab business processes, drug development experience an advantage
+ Ability to break down problems, build requirements for development tasks in an agile manner.
**Desired Characteristics:**
+ Experience with Cloud technologies, Java, JavaScript, JBoss, SQL, Windows Server, Citrix, Integrations
+ Experience working in remote / global teams.
+ Entrepreneurial mindset - champions new technology, predicts trends, and identifies new opportunities based on trends. Ability to make technology choices based on experience and willingness to take calculated risks and experiment with newer technologies.
+ Ability to develop partnership with stakeholders and develop an inclusive & collaborative environment.
+ Ability to effectively present portfolio, project plans, technical roadmaps, risks and recommendations to senior business leaders
+ Certifications such as CSBA, CBAP, or PMP
**Leadership:**
+ Pre-emptively sees downstream consequences and effectively tailors influencing strategy to support a positive outcome.
+ Able to verbalize what is behind decisions and downstream implications. Continuously reflecting on success and failures to improve performance and decision-making.
+ Understands when change is needed. Participates in technical strategy planning.
**Inclusion and Diversity**
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
**Behaviors**
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-BG1
#LI-onsite
**Additional Information**
**Relocation Assistance Provided:** No
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Technician, Pharmaceutical

Sligo, Connacht AbbVie

Posted 12 days ago

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Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
What you do, is what we need. Making a difference begins here. And takes all of us.
Welcome to AbbVie!
We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
We are recruiting a Pharmaceutical Technician to join our team on site in Manorhamilton Road, Sligo on a 12 month fixed-term contract. This role is rotational shift work.
In your role as Pharmaceutical Technician you will be responsible for producing drug product materials as per organizational needs in line with all relevant compliance requirements. This person will operate as a team member in a pharmaceutical processing facility in line with all regulatory and organizational requirements.
Are you intrigued? Do you want to learn more?
A snapshot of your key responsibilities as a Pharmaceutical Technician would be:
+ Pharmaceutical processing activities in our manufacturing building and support locations.
+ Team co-ordination to maximise the effectiveness of the team members.
+ Documentation of all activities in line with cGMP requirements.
+ Cross training within the team and training of new team members.
+ Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
+ Execution of commissioning and validation protocols on an ongoing basis.
+ Maintaining the overall cGMP of the pharmaceutical processing areas.
+ Adheres to and supports all EHS & E standards, procedures, and policies.
Qualifications
In this role you will need;
+ 3rd level qualification, preferably in Engineering or Science related fields OR 2+ years in a GMP regulated environment
+ Experience of operating in a highly automated environment
+ Experience in safe handling of dangerous chemicals is desirable
+ Good I.T. skills are required.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Technical Writer - Pharmaceutical Manufacturing Operations

Cork, Munster Cpl Resources

Posted 1 day ago

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Contract type - Permanent Work model Hybrid ( 3 days / week from office) Working hours - 39 per week At Covalen, we're not just a business process outsourcing (BPO) service provider we're industry pioneers collaborating with organizations worldwide for over 25 years. From established sectors to cutting-edge industries, our tailored BPO solutions forge powerful partnerships, helping clients achieve their unique goals. We've built enduring relationships in Financial Services, Technology, and Utilities, working with some of the globe's largest and most forward-thinking companies. Job Description: Supporting Pharmaceutical Manufacturing Operations and Technical groups to; Own document revision and routing on document management system and drive on time approval Design, update and improve facility/process procedures and business processes. Design, update and improve Manufacturing Batch Records. Design, generate and update Operations Area Logbooks Design, generate and update Training Documentation Design, update and improve EH&S systems and documentation. Design and generate PQ Protocols Design update/improve other documentations associated with the large molecule business. Managing documents in the site documentation management system in line with the site quality assurance program and local standard operating procedures. Opportunity to: Support a dynamic Large Molecule manufacturing environment. Develop/learn key understanding of core manufacturing principles. Involvement in New Product Introductions (NPI). Deliver in innovative Manufacturing Areas. Support multiple manufacturing functions (Eng, Chemistry, QA, EHS, Micro) Requirements: Relevant engineering/ science 3rd level qualification or operational experience Masters in engineering / science is desirable Previous pharma production, operations/ projects/process experience Strong sense of customer focus and teamwork Previously demonstrated flexibility and willingness to take on different job tasks Self-motivated/ proactive approach with the ability to operate without close supervision Proven ability to deal with unexpected issues using problem solving skills Commitment to meet deadlines Right first time attitude. Demonstrated technical writing skills in the generation of documents and high level of IT skills Good planning and organisation skills essential Equal opportunity employer: At Covalen, we champion diversity and equality, anchoring our workplace cultures and creative minds. We recognize the collective strength found in the diverse backgrounds, skills, and experiences of our team members. Our commitment to fostering an inclusive environment transcends gender, marital status, family status, age, disability, sexual orientation, race, religion, and membership in the Travelling community. For more information, don't hesitate to reach out your journey to becoming a valued part of Covalen starts here. Apply Now or Reach Out for More Information. #CovalenLinkedIn #CplCovalen #Jobsinireland #Covalen
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Pharmacovigilance Officer

Dublin, Leinster TCP Group

Posted 2 days ago

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TCP Homecare is a healthcare service provider, specialising in direct to patient services which include the dispensing and distribution of pharmaceutical products, home care nursing services and sharps waste management, facilitating a unique turnkey solution for the delivery of hospital care in the patients home. We are looking for a pharmacovigilance officer for a permanent role, who demonstrates a high degree of self-motivation and the ability to adapt to change. This role is ideally suited to a recent graduate looking to gain experience in pharmacovigilance. Key Responsibilities: Process PV events, and product quality complaints in line the organisations operating procedures Perform mailbox triage and management, case processing, reconciliation, query management and other tasks to ensure compliance with pharmacovigilance procedures. Be involved in carrying out regular reconciliation of case reports with internal and external sources. Ensure compliance with internal TCP SOPS and other relevant procedures where applicable Maintain the Pharmacovigilance reporting system as well as provide systematic reporting to in-house managers and external clients. Dealing with external pharmaceutical departments and other multidisciplinary teams. Maintain customer confidentiality at all times. Assist in the development of pharmacovigilance procedures. Act as a key information resource to pharmacovigilance team and other multidisciplinary teams. In compliance with client requirements ensure that all service user records and files are managed, maintained and up to date Create incidents reports that occur in PV and drive the actions that are required remediate errors. This may require liaising directly with other functional leads to align processes to PV standards. Adhere to GVP (good pharmacovigilance practices) guidelines at all times. Perform other duties as assigned by PV Manager Represents self in a professional and ethical manner at all times, complying with all applicable company policy and procedures Role requirements: Degree in life sciences or working towards, highly desirable. High degree of accuracy with attention to detail essential. Familiarity with good pharmacovigilance practices (GVP) desirable. Knowledge of medical and drug terminology would be a distinct advantage. Good written and verbal communication skills. Ability to work independently with moderate supervision. Good knowledge and experience using MS Office would be beneficial. What We Offer in Return: Competitive annual salary 24 days of annual leave, rising with service Pension Scheme Life Assurance Health Insurance Income Protection Education Assistance funding with paid exam and study Leave Employee Discount Card You Can Also Expect: A supportive and friendly working environment Regular training courses and opportunities to up-skill Promotional opportunities Refer a Friend scheme Social events Cycle to Work scheme Skills: GVP Medical and drug terminology Communication
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EHS Engineer - Pharmaceutical Manufacturing - Dublin

Dublin, Leinster SSA Recruitment

Posted 3 days ago

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Our client is a Global Multinational Company who have a significant amount of work throughout Ireland, and this would be a fantastic company to help you further your career in Health & Safety. This is a permanent position. About the role: EHS Engineer Dublin Based position Full Time Permanent Role Competitive Salary & Package €50,000 - €55,000 + Bonus & Benefits Your main duties will include, but not be limited to: Developing, implementing and monitoring environmental, health & safety programs to ensure compliance with all applicable government regulations and company standards and values. Driving effective writing/revising/rolling out of accurate operational procedures, training materials and EHS related procedures. Coordinate and conduct internal EHS auditing and inspection ensuring actions are tracked to closure. Coordinate and ensure compliance with legislation and company technical standards regarding contractor management. Managing technical activities to progress projects and investigations. To be successful in your application you will ideally possess the following: Relevant EHS Qualification. 1+ years experience in Manufacturing Desirable Excellent communication skills If you are interested in this position, please reach out to Conor O'Donnell at SSA Group for a confidential discussion, or apply now. Skills: EHS Environmental Health & Safety Health & Safety Benefits: & Package
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Senior Pharmacist

Westmeath, Leinster recruitNet

Posted 464 days ago

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Permanent
RecruitNet International Ltd  is Specializing in relocating Qualified professionals throughout Ireland and overseas, we guide you through the professional registration, job placement, visa and employment permit processing. We the RecruitNet team are always on call to help. You find your perfect job and it is staffed by highly experienced and professional nursing recruitment consultants.  We are urgently seeking Senior Pharmacist  for a private hospital in Westmeath Ireland.  Key Responsibilities   Responsibility for managing stock supply, rotation, disposal, and minimizing wastage falls under this role.Maintaining accurate records of all medications and intravenous fluids is essentialadministration of medications and ensuring the safe, appropriate, and cost-effective use of medicines.Collaborate with the multidisciplinary team to provide and promote high-quality, cost-effective, patient-focused pharmaceutical care that prioritizes safety.promotion of safe drug usageResponding to medication related queriesLiaise with other fellow healthcare professionals to ensure the delivery of safe, effective and economic drug treatment. Ensure all details of dispensing conform to legal requirements and professional standards in the provision of medication to the departments in CMPH. Requirements Registered Pharmacist with the Pharmaceutical Society of Ireland (PSI) or eligible for registrationHospital experience is essential must have the necessary knowledge and skills to fulfill the responsibilities of a Pharmacist effectively.A minimum of 3 years of post-qualification experience in a hospital pharmacy (preferred) and/or community setting is required for this positionEffective communication skills and a commitment to quality in all tasks and work practices, including accuracy and attention to detail, are essential qualities for the ideal candidate. BenefitsCompetitive salarySigning bonusFree staff car parkingFlexible hoursTraining and development opportunitiesOther paid leavesSick payPRSA Contribution 
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