Want to make a global impact? We offer that.
Want to be part of a Great Place to Work in Ireland? We offer that too.
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 Qualified Person (QP) to join our join our team in our Cork site (Carrigtwohill). This person will act as Qualified Person in compliance with the regulatory and legal requirements of this title. They will contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.
Are you intrigued? Do you want to learn more?
A snapshot of your key responsibilities as Qualified Person (QP) would be:
- Completion of PQR, Batch record Updates
- Review of and updating regulatory filings as needed
- Completing quality assurance review of batch documentation as required
- Supporting RCA , CAPA & Change Mgt Process
- Reviewing and assessment of GMP critical systems
- Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients, propose corrective actions and check that they are applied.
- Participate in technical and scientific meetings, in training days, trade fairs, conferences… (technological intelligence…). Provide to operations all guidelines and documents.
- Keep up to date with the Regulation Evolution
- Contribute to the Quality Assurance Plan Realisation
- Implementation, maintenance, and development of QA systems.
- Reviewing the GMP documentation e.g., SOPs, reports, methods, specifications, validation protocols, quality contracts, batch records etc., and Exception Documents e.g. NCRs, PRA’s etc.
- Writing and reviewing QA department procedures and reports e.g. protocols, SOPs, environmental reports etc. Reviewing and approving other departmental procedures and reports.
- Contribute to the quality assessment of clinical, pre-commercial product, and IMPs
- Product release activities
- By performing investigations, and ensuring a follow-up, following discrepancy, failures, and external complaints.
- Facilitating RCA sessions
Education and Qualifications:
- Education to meet the requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16
- Experience of GMP auditing and documentation
- Previous management / supervisory experience an advantage
- Ability to critically assess issues and execute problem solving
- Fluent written and verbal English
So, are you ready to join our team?
It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.
Travel: Yes, 5 % of the Time
Job Type: Experienced