QA Manager, Pharmaceutical
Location:
Type: Permanent
Salary: £58000-£65000
The Role
* Directly managing a team of quality professionals, conducting regular (1-1) meetings, performance reviews, career development planning for all direct reports.
* Recruiting and onboarding of new staff members.
* Setting objectives for the team and providing regular feedback (and coaching).
* Developing, implementing and maintaining a comprehensive QMS suitable for both pharmaceutical and food/ingredients products.
* Championing improvements through risk management & route-cause analysis.
* Responsible for the functioning of the QMS, providing oversight to key stakeholders alike (including senior staff members).
* Accountability across (but not limited to); change control, stability, documentation control, internal audits, GMP, supplier approval, complaints, PQRs, NPI, route cause analysis and controlled drug returns.
* Ensuring compliance/ correct documentation practices, i.e batch records, laboratory tests and quality agreements too.
* Overseeing supplier verification & vendor- auditing programs.
* Managing the batch review process.
* Keeping abreast of evolving UK & EU retained regulations (for the purposes of pharmaceutical and/or food/ingredients manufacturing).
* To ensure compliance with EU GMP standards & BRC food safety requirements.
* Managing the preparation process (and heavily involved in hosting activities) for MHRA inspections, customer (third party audits) and acting as the lead person.
* Enrsuring quality goals/ agreed time-frames are met and providing measures for the QA to the HOQ.
* Responsible for the day-day operational functions of the quality team, ensuring flow of products through product life‑cycle and batch review processes.
* Developing training programmes.
* Responsible for external communication with regulatory bodies.
* Deputising for the HOQ when required.
The Person
* ØThe ideal Candidate will hold a degree in a STEM related subject
* ØExperience managing QA team/s in an GMP/ Pharmaceutical setting.
* ØManagement experience essential (will consider Team Leader or similar).
* ØExperienced in batch review and batch release
* ØExperience in auditing and audit hosting
* ØExperience in CAPA, deviations, change controls, internal auditing (preferred) etc
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