Description
Global Bio Pharmaceutical company based in Dublin are currently going through an exciting growth phase. 3 new products are being transferred on site and they are currently seeking a QA Manager to lead the tech transfer, ensuring the new manufacturing facilities are designed built and qualified in a manner that is compliant with the companies' standards and procedures. Due to the sites success to date they have receive repeated investment.The successful candidate will be supported by a highly skilled QA team, and will be responsible for networking within the site looking and pulling the needed skills and people to ensure the successful transfer.
The QA Manager will lead the tech transfer project and help build and mentor the QA team.
The large sized internal award winning QA team is highly energetic, proactive and proud of how successful the site has been.
Day to Day:
- Provide quality and compliance guidance and support to the Operating Unit, ensuring appropriate Standards and GMP requirements are met for product transfers and the associated validation of product, process, equipment and facility.
- Ensure all validation documentation is generated and executed in a manner that complies with Standards and local SOPs to ensure successful PAI regulatory and Corporate inspections.
- Participate in assessments and meetings at the respective sending sites in order to contribute to manufacturing gap assessments and quality risk assessments associated with product transfers.
- Ensure that production instructional documentation (SOPs and batch records) are up to date, compliant, and supports efficient production, ensuring all steps have been performed and verified, that all limits and specifications have been met.
- Support Manufacturing Operations in the investigation, reporting and timely resolution of batch & validation deviations, identification & timely implementation of appropriate CAPAs and monitoring the effectiveness of relevant changes.
- Manage the review and disposition of demo and PV batches, in liaison with the appropriate QP, to ensure disposition & project schedules are met.
- Be a key contributor to the respective Quality Operations forums including local Compliance, Business Review, MRB (Materials Review Board), Tech & Reg, Validation and SQRT (Site Quality Review Team) meetings.
- Responsible, in conjunction with other OpU Leadership, for the representation of the product transfer at respective FDA, HPRA and other BOH Regulatory PAI as well as MSQA Corporate Inspections.
- Conduct routine cGMP compliance and RFT area walkthroughs of Manufacturing Operations.
- Oversee the development of a team of Quality project professionals within the OpU.
- Report on project progress to the Quality Operations Leadership Team
- Escalate issues as appropriate to the Site Head of Quality Operations in a timely manner
- Participate in cross-functional teams as required.
- Perform and assist with additional duties as may be directed by the Site Head of Quality Operations
Education/Experience
To be successful in this role the following are prerequisites to application:
- Hold a B.Sc. degree in biological/chemical sciences or other related technical degree or equivalent experience in regulated industry.
- Preferable 8 years' experience in quality assurance in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment.
- People management experience is desirable
- Specific experience in Tech Transfer and Validation (process and equipment) of a biological product
- Have experience in representing your functional area on a network team
- Experience of involvement in technical issue resolution, in a multidisciplinary environment
- Excellent communication and interpersonal skills. Demonstrated skills in successful collaboration
- Proven record in demonstrating agility
- Travel at short notice may be required
A market leading salary and benefits package is on offer with the role.
If you are interested in this excellent opportunity please apply below with an up to date CV. Not sure yet? No CV ready? Give me a call for more information Anna Mooney .