QA Manager, Pharmaceutical

Russell Taylor Group Ltd; Hitchin; On-site; GBP 58,000 - 65,000; Full time

Job summary

A leading pharmaceutical company in Hitchin is looking for a QA Manager to oversee the Quality Management System and manage a team of quality professionals. The ideal candidate will have a degree in a STEM field and relevant experience in QA management within GMP settings. This role offers a salary range of £58,000 to £65,000 with a focus on regulatory compliance and quality assurance.

Qualifications

• Experience managing QA teams in a GMP/Pharmaceutical setting.
• Able to conduct performance reviews and career development planning.
• Familiarity with EU GMP standards & BRC food safety requirements.

Responsibilities

• Directly managing a team of quality professionals.
• Developing, implementing and maintaining a comprehensive QMS.
• Ensuring compliance with UK & EU regulations.

Skills

Team management

Quality Assurance

Regulatory compliance

Batch review

Change control

Education

Degree in a STEM related subject

Job description

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