QA Stability Manager
Grange Castle, Dublin
CPL in conjunction with our client - one of the world's biggest Biopharmaceutical Company, is looking for a QA Stability Manager to join their Grange Castle site in Dublin.
Permanent role with an attractive salary and additional benefits.
This role will have oversight on all stability programs executed at the Grange Castle site. teams. It is a very dynamic highly visible role which is critical to day to day activities on the site as it interacts with multiple site functions and Network Teams. This role will include the support of site projects, regulatory filings and post approval stability commitments. The successful candidate will be an individual with the ability organize and manage a complex area, and optimize process robustness/efficiency, so that the team can respond to current needs and also address future activities for Grange Castle.
- Lead and co-ordinate all activities within the remit of the Stability team. Responsible for day to day activities of the team.
- Represent QA Stability at product, technical and robustness team meetings and lead/drive all associated support activities.
- Liaise between the team and all customers (both internal and external Company Network).
- Participate in cross-functional teams as required where strategic leadership is required.
- Challenge and develop talent QA Stability team.
- Appropriately delegate workload to drive project timelines in a compliant manner, based on experience, knowledge and history of previous projects. Identify strengths and talents within the team drive this delegation.
- Contribute to promoting a ‘Right First Time’ and ‘Continuous Improvement with the project/stability quality and wider teams, by using analytical tools, introduction / updating of site systems and solutions
- Support Operations teams with investigations and resolution of discrepancies; provide consultative support on stability related issues to Manufacturing Operations.
- Oversee stability programs supporting post approval stability commitments and regulatory filings
- Oversight on the implementation and lifecycle of Informa builds for QA Stability
- Ensure that activities are performed in a manner which is compliant with Pfizer Quality Standards and Grange Castle Standard Operating Procedures.
- Represent and support the team to ensure team, Quality OpU and site metrics are met.
- Ensure issues are escalated as appropriate to QA Lead for Tech Transfers and SQOL, and that feedback is sought in a timely manner.
- Ensure weekly, monthly, quarterly and annual reports are generated in a timely manner
- Use visual management to track and trend activities required.
- Regularly report out to management on achievements and challenges.
- Ensure that GC Quality system SOP (Deviations, Change Control) are applied as appropriate
- Lead continuous inspection readiness for QA Stability
- Drive a culture of continuous improvement within QA using IMEX and other Company Digital tools.
- Enhance agility and flexibility within the team and across teams.
- Perform and assist with additional duties as may be directed by the QA Lead
- Act as delegate for QA Lead Tech Transfers as required
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.
- Min. 5-10 years quality experience in a biotech, pharmaceutical, or bio- pharmaceutical manufacturing environment.
- Excellent organizational skills
- Ideal candidate should have good knowledge in analytical testing and technical transfer of new products to site
- Experience of involvement in technical issue resolution, in a multidisciplinary environment
- Excellent communication and interpersonal skills.
- Demonstrated ability to successfully collaborate, influence and lead in a matrix organization
- Proven record in demonstrating agility
Interested candidates please send your CV to Shyni.Fernandez@cpl.ie and we'll be in touch soon!