What Jobs are available for Pharmaceutical in Ireland?

Showing 12 Pharmaceutical jobs in Ireland

Pharmaceutical Technician

Sligo, Connacht AbbVie

Posted 25 days ago

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Job Description

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
All your information will be kept confidential according to EEO guidelines.
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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QA Regulatory Compliance Specialist

PCI Pharma Services

Posted 22 days ago

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Job Description

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.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
#LI-JP1
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
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Director, Quality & Regulatory

Galway, Connacht Medtronic

Posted 25 days ago

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Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Medtronic is hiring a Quality System Director. The person is Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
**Responsibilities may include the following and other duties may be assigned:**
-Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
-Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
-Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
-Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
-Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
-Co-ordinates legal requests in support of government investigations or litigations.
-Ensures the quality assurance programs and policies are maintained and modified regularly.
-Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
**Required Knowledge and Experience:**
-Autonomy: Manages department (s) or small unit that includes multiple teams led by managers and / or supervisors. Provides motivational leadership for the area managed. Provides thought and technical leadership. Performs work without appreciable direction.
-Organizational Impact: Leads the development of the strategy for own department or business area, ensuring links to the company's aims and objectives. Management authority to make large business decisions and some strategic decisions. Decisions impact the financial performance, employees, or public image of the operational unit and/or company. Typically has budget or P&L accountability for a department, broad functional area or geography.
-Innovation and Complexity: Drives innovation across the business area, encouraging best practice and knowledge sharing. Significantly improves, changes or adapts own department or business area's processes, systems, products or services. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.
-Communication and Influence: Develops long term strategic relationships and alliances with key internal and external stakeholders. Communicates and conducts briefings with senior or executive leadership regarding ongoing operations and strategic initiatives. Influences across functions and businesses to negotiate and gain cooperation on operational issues and internal divergent objectives.
-Leadership and Talent Management Directs and leads a department, broad functional area or geography, including one or more teams led by managers and / or supervisors. Determines supervisory relationships and creates workforce and staffing plans to accomplish business results. Authorizes hiring, firing, Job Description promotion and reward within own area.
-Requires broad management and leadership knowledge to lead multiple job areas, and detailed functional and operational expertise. Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
This position is eligible for an annual long-term incentive plan.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
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Senior Project Manager - Pharma Labs

ThermoFisher Scientific

Posted 25 days ago

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Sr Project Manager - Pharma Labs**
**Remote opportunity**
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 guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
As a Senior Project Manager you will work for our GMP Labs in Athlone where we provide analytical services to our clients. You would have responsibility for managing and direct oversight for a portfolio of projects for a specific client and be accountable for overall project/portfolio performance.
**A day in the Life:**
+ Proactively identifies resources and budgets projects
+ Prioritizes client's portfolio in line with site-wide portfolio of projects and is the primaryoperational interface between the business and the client.
+ Negotiates and makes real-time decisions with the client.
+ Provides internal consulting on project management issues and identifies opportunities for process and efficiency improvement.
+ Acts as chief liaison to the operational personnel of major clients and is responsible for large study programs.
+ Provides oversight and coordination of client portfolio. Provides oversight to internal departments and external clients to ensure the project requirements are understood, agreed and followed at all times, this requires negotiating and real time decision making with the client.
+ Facilitates the flow of technical and clinical laboratory information to all stakeholders
+ Consults and utilizes, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the project
+ Prepares the project specifications documents and follows the preparation according to budgets and contracts. Maintains at all times an updated project master file with version controls for specs, budgets and contracts.
**Keys to Success:**
**Education** **& Experience**
+ Bachelor's in a scientific discipline
+ 8+ years experience in (pharmaceutical) project management
+ Executive level presentation experience
**Knowledge, Skills, Abilities**
+ Strong science and/or business acumen
+ Strong verbal, written and presentation skills
+ Superior time management, planning, and organizational skills
+ Proven analytical skills
+ Demonstrated compliance with procedures and policies
+ Ability to perform multiple tasks effectively in a stressful environment
+ Extensive knowledge and experience in Project Management
+ Strong client relationship management skills
+ Ability to work effectively with multi-level teams
+ Ability to work in a fast-paced undefined environment
+ Strong negotiation skills
**Benefits**
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
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.
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.
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Sr Research Scientist - Pharma

Athlone, Leinster ThermoFisher Scientific

Posted 25 days ago

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Senior Research Scientist - Pharma**
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 guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Our GMP Lab in Athlone conducts testing for clinical programs and marketed products across all phases of drug development and this role is based in our Pharma lab.
**Discover Impactful Work:**
The Senior Research Scientist - Pharma oversees complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.). Provides technical and regulatory consulting to internal groups and clients about their programs. Provides technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely acts as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.
**A day in the Life:**
+ Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements.
+ Acts as on-site Subject Matter Expert (SME) for various instrumentation / technique / technology and validation/method transfer.
+ Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical applications.
+ Demonstrates viability of in-house developed methods and methods transferred from clients by designing appropriate validation experiments or other appropriate aspects of specialty methodology or technology.
+ Ability to lead client discussions regarding project definitions, technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues.
+ Reviews protocols, project status reports, final study reports and other projectrelated technical documents.
+ Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
+ Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
**Keys to Success:**
**Education & Experience**
+ Educated to a bachelor's degree level in a relevant Scientific area, ie chemistry, biochemistry
+ 10+ years' relevant industry experience within a 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**
+ Effective written and oral communication skills as well as presentation skills
+ Knowledge and application of industry best practices not yet represented by global regulatory requirements
+ Effective, proven experience with method development, validation and the associated regulatory and ICH requirements of same
+ Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
+ Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
+ Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
+ Ability to independently review and understand project proposals/plans
+ Proven ability in technical writing skills
+ Ability to work in a collaborative work environment with a team
+ Proven problem solving and troubleshooting abilities
+ Ability to independently optimize analytical methods
+ Time management and project 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. 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 *. 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.
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Sterility Assurance Lead

Sligo, Connacht AbbVie

Posted 25 days ago

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Job Description

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
We are hiring a Sterility Assurance Lead to join our quality organisation in AbbVie Biologics, Ballytivnan in Sligo. In this key role, you will ensure that all products from our facility meet the highest standards for both marketed and investigational drug products. This is an exciting opportunity for a proactive leader to influence and shape sterility assurance and contamination control strategies at a leading biopharmaceutical site, while working cross-functionally with global and local teams.
Responsibilities
+ Own and continually develop the site's Contamination Control Strategy.
+ Collaborate with Operations and QC Micro Lab to design and deliver robust training programs on aseptic processing, aseptic behaviors, and principles for site staff.
+ Develop, implement, and monitor gowning, cleaning, and sanitization strategies in conjunction with relevant stakeholders.
+ Establish and maintain environmental monitoring and clean utilities programs.
+ Serve as subject matter expert on sterility assurance during regulatory inspections, audits, and cross-functional initiatives.
+ Guide the investigation of contamination-related non-conformances and events, and provide technical input to microbiological method transfers.
+ Analyze and review microbiological data to identify trends and implement effective risk mitigation.
+ Liaise with global Science & Technology functions to ensure site alignment with industry best practices and regulatory requirements.
+ Maintain compliance with governing regulations and lead by example in promoting best contamination control practices through ongoing training and floor presence.
+ Support continuous improvement initiatives, corrective action implementation, and efficient quality-operations relationships.
Qualifications
Qualifications
List required and preferred qualifications (up to 10). Include education, skills and experience.
+ BS in science or equivalent (Chemistry, Microbiology, or Biology preferred)
+ 2-5 years of laboratory experience
+ 2-5 years of supervisory experience
+ Demonstrated skills to deal effectively with members of the department and the areas serviced by the laboratory
+ Problem solving skills are required
+ Must be able to interpret impact of laboratory data for appropriate and effective actions
+ Must be able to identify problem areas requiring development, maintenance, production, engineering, accounting, or planning with assistance from more senior staff
+ Must also be able to identify, communicate, and follow-through to completion and assist in the development of necessary corrective action plans to resolve the problem with supervision. May also assist in the activities required for the investigation and resolution
Additional Information
+ Bachelor's degree or higher in a relevant technical discipline (science or engineering); Microbiology qualification is desirable.
+ Minimum 4-5 years' experience in the pharmaceutical or biopharma industry within a Quality or Operations function, preferably in a GMP environment.
+ At least 1 year of experience in an aseptic sterile fill-finish manufacturing environment and 1 year in a microbiological role supporting such environments.
+ Proven ability to work cross-functionally and influence site teams in a highly regulated setting.
+ Strong understanding of regulatory requirements related to sterility assurance and compliance.
AbbVie is committed to fostering a diverse and inclusive workplace. If you are enthusiastic about quality, compliance, and continuous improvement, we encourage you to apply and help shape the future of sterility assurance at our Ballytivnan site. For more information about AbbVie, please visit 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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Pharma Account Manager

Dublin, Leinster UnitedHealth Group

Posted 25 days ago

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Job Description

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together.
**About the Role:**
As a Fortune 5 business, we're one of the world's leading healthcare companies. There are no limits here on the resources you'll have or the challenges you'll encounter.
We have been supporting global healthcare systems from Ireland and the UK for more than 20 years, building a dynamic and diverse team of more than 2,100 talented individuals. With a continued record of growth and stability, we're on the constant lookout for fresh talent to join our expanding teams.
We are looking for an experienced, curious and self-motivated individual who will be responsible for working within a Pharma Services team dedicated to providing key account management to major Pharmaceutical Manufacturers based in the US. The successful candidate will report to the Director of Pharma Services, Emisar. We are looking for people who can collaborate cross-functionally with various business and data analytics teams, demonstrate exceptional attention to detail, have a customer focused mindset, and the ability to manage multiple competing business projects at one time.
_Careers with Optum offer flexible work arrangements and individuals who live and work in the Republic of Ireland will have the opportunity to split their monthly work hours between our Dublin or Letterkenny offices and telecommuting from a home-based office in a hybrid work model_
**Primary Responsibilities:**
- Perform within a team of account and service managers aimed at developing and promoting net new administrative services for Pharmaceutical Manufacturers based in the US.
- Work with key business owners to lead, inform, and direct the development of an extensive portfolio of new and innovative GPO tools and services that will be delivered to Pharmaceutical Manufacturers in 2026 and 2027. Ideation, scoping of work, and UX consulting throughout 2024, with product development, value optimization, testing, and stakeholder engagement throughout 2025 and 2026.
- Coordinate with GPO Business Development team to maximize efforts to improve operational efficiency, centralization of data, utility of dashboards and business tools, and other initiatives to improve overall competitiveness and profitability.
- Be involved in the operational activities related to Pharma Services.
- Provide executive summaries to senior individual(s) including the organization of presentations and the analysis and interpretation of information/data.
- Actively seeks to improve current and future processes and coordinate organizational procedures for optimized efficiency.
- Work towards objectives and deliverables, and work across cross-functional teams to deliver against initiative.
- Manage regular reports and updates for the leadership team, and executive team reflecting business performance and priorities.
- Create and articulate business case for highest impact product opportunities.
**Required Qualifications:**
- Undergraduate degree or equivalent.
- 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 work on projects with accountability of work to senior management level stakeholders.
- Understanding of competitive landscape and familiarity with pharmaceuticals or healthcare industry.
- 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.
**Preferred Qualifications:**
- Experience in managed health care or pharmacy benefit management
- Advanced degree (e.g. MBA)
**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. © 2023 Optum Services (Ireland) Limited. All rights reserved.
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Senior Clinical Data Team Lead (Senior DTL) - FSP

Dublin, Leinster IQVIA

Posted 25 days ago

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Job Description

The Sr. CDM will lead and contribute to data management activities in support of Client's studies across all stages of clinical drug development.
**Summary of Key Responsibilities**
+ Contribute to data management activities as a lead study data manager in support of Client's clinical studies
+ Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing
+ Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
+ Oversight of database lock activities and ultimate archiving of study data
+ Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors
+ Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
+ Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
+ Contribute to development and implementation of department workflows and infrastructure strategy (such as preferred provider interactions, SOPs, and templates) that reflects data collection standards, consistent with industry best practice and regulation
+ Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
+ Participate in the training of external vendors and site staff
+ Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met
+ Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
+ Support GCP inspection readiness
**Qualifications**
+ BS/BA in scientific discipline,
+ At least 7 years related experience in a pharmaceutical/biologics/biotechnology company
+ Experience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferred
+ Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
+ Knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH
+ Experience working with Medidata Rave
+ Experience using standardized medical terminology, including MedDRA and WHODrug
+ Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project
+ Excellent written and oral communications skills
+ Highly motivated and flexible, with excellent organizational and time management skills
+ Ability to work independently and as part of a multi-disciplinary team
+ Understanding of ICH GCP as well as general knowledge of industry practices and standards
+ Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
+ NDA/MAA experience
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Qualified Person

Sligo, Connacht AbbVie

Posted 25 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
The Qualified Person (QP) at AbbVie Biologics Ballytivnan Sligo is responsible for ensuring the compliance and quality of our pharmaceutical products. This role requires expertise in quality assurance practices within an FDA and EMEA approved environment to maintain product safety and integrity. As a QP for the site, you will work closely with our products throughout their manufacturing lifecycle, up until release from the site.
Responsibilities
+ Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice and Annex 16 requirements.
+ Certify that each batch is manufactured and checked according to relevant laws, GMPs, and product specifications at AbbVie Biologics Ballytivnan Sligo.
+ Oversee the disposition of bulk products, determining release or rejection based on manufacturing and testing data.
+ Assess and resolve day-to-day quality issues, ensuring products meet quality and safety standards.
+ Support cross-functional teams in process improvement and cost efficiency initiatives.
+ Provide technical leadership and collaborate with stakeholders to enhance product quality and process optimization.
+ Make informed decisions within quality systems, adhering to regulatory standards, and handle quality queries from the operations team.
+ Promote a culture of excellence in quality and compliance throughout the organization.
+ Participate in internal and external audits, ensuring readiness and compliance with quality standards.
Qualifications
+ Essential: Bachelor's degree in a science discipline and a minimum of 5 years of experience in the pharmaceutical industry.
+ MSc in Industrial Pharmaceutical Science or equivalent recognized for QP status under Directive 2001/83/EC, Article 49.
+ Experience as a QP on a license preferrable
+ Experience in aseptic processing and quality functions.
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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Clinical Trials Nurse

Dublin, Leinster recruitNet

Posted 2 days ago

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Job Description

Permanent

RecruitNet International Ltd specialises in healthcare recruitment for both domestic and overseas candidates across Hospitals, Nursing Homes, Home Care, and Community Care settings.

We are currently hiring a Clinical Trials Nurse for a leading hospital in Dublin, Ireland

Hours per week; 37 hours per week   Key Responsibilities

Provide high-quality nursing care to clinical trial participants, including screening, consenting, administering treatments, monitoring, and follow-up.

Educate participants and their families on study procedures, potential risks, and benefits.

Ensure accurate and timely documentation of all trial-related procedures, interventions, and outcomes.

Support Principal Investigators and research teams in implementing study protocols.

Administer investigational products (oral, IV, injection, etc.) safely and in accordance with protocol and nursing standards.

Monitor participants for adverse events, report findings promptly, and contribute to safety management.

Maintain compliance with ICH-GCP guidelines, research ethics, and institutional policies.

Participate in site initiation, monitoring visits, audits, and inspections as required.

Assist with trial logistics, including scheduling, data entry, sample handling, and record keeping.

Act as a liaison between participants, clinical teams, and study sponsors/CROs.

Support research dissemination activities as needed.

RequirementsEducation:

Degree in Nursing – Required

Postgraduate qualification in Research Methodology – Desirable

Experience:

Substantial experience working in an acute hospital setting at a senior nursing level.

Minimum 3 years’ experience in Acute Medical Oncology.

Demonstrated experience in phlebotomy, IV insertion, and administration of investigational products.

Familiarity with the informed consent process and participant communication.

Knowledge of adverse event reporting and pharmacovigilance processes.

Understanding of sample management and chain of custody procedures.

Proven experience in collating, managing, and reporting complex clinical data

BenefitsFully Funded Private Health InsuranceGenerous SalariesEducational SupportExcellent Career OpportunitiesIncome ProtectionSubsidised ParkingMaternity Leave
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