Job Description
An amazing opportunity has arisen as a Senior QA Specialist in the Centre of Excellence (COE) Quality Systems team, supporting activities in both the Drug Substance and Drug Product facilities on site.
The ideal candidate will have a strong background in quality validation, risk management, and internal auditing within a regulated environment. This senior role will champion QRM activities across the site and will provide quality leadership during the review of process and analytical validation documents.
The Senior Quality Specialist is a self-directed decision-maker responsible for managing and overseeing the Quality Management Systems in a diverse organization that manufactures Drug Product, Drug Product Intermediate, and Drug Substance. The successful candidate will ensure the timely and effective completion of the Quality Systems core functions in accordance with site schedules, policies, procedures, and guidelines. Sound judgment to make well-informed decisions is essential.
What You Will Do
1. Quality Risk Management Champion: Act as the Site Topic Lead (STL) for QRM, facilitating assessments, ensuring adherence to schedules, and chairing QRM meetings to promote a culture of risk awareness and inspection readiness.
2. Risk Register Maintenance: Initiate QRM plans, maintain, and ensure the accuracy of the risk register.
3. Metrics: Participate in generating and communicating quality metrics related to QRM.
4. QA Validation Lead: Oversee review of validation documents, ensuring compliance with regulatory and company standards.
5. Validation Committee Chair: Schedule and lead validation meetings, define agendas, facilitate discussions, and ensure documentation.
6. Support Validation Activities: Assist in validation for PPQ and commercial batches, approve documentation, and develop summaries.
7. Lead Auditor: Conduct internal audits, communicate findings, and collaborate on resolutions.
8. Regulatory Inspection Support: Provide front-facing support during inspections and manage the backroom team.
9. Change Control Assessment: Review CRs related to processes and methods, ensuring compliance throughout all stages.
10. Deviation Assessment: Analyze deviations for impact and compliance.
11. Cross-Functional Project Management: Manage projects ensuring timely delivery and quality alignment.
12. Continuous Process Improvement: Identify and drive process improvement initiatives.
What Skills You Will Need
1. Degree or post-graduate qualification in Science, Pharmacy, or equivalent.
2. Knowledge of Quality IT systems (e.g., SAP, LIMS, QSAT, Quality Docs) is desirable.
3. Expertise in Lean / Continuous Improvement.
4. Proven Leadership Skills.
5. Experience with GMP requirements for electronic/paper-free operations.
6. Experience in Drug Substance/Drug Product manufacturing, validation, QRM, and project management is desirable.
We are committed to ‘Inventing for Life’ and keeping the patient at the heart of our work. We value diversity and inclusion, believing that innovative breakthroughs come from diverse ideas in an inclusive environment.
If you are ready to invent solutions, impact healthcare, and inspire your team, please apply today.
#J-18808-Ljbffr