Pharmacy QA Manager

About HMR Hammersmith Medicines Research (HMR) runs early-phase (Phase I) clinical trials, supported by an MHRA-licensed pharmacy that manufactures investigational medicinal products under GMP, including aseptic operations. HMR is based at Park Royal, London. HMR is part of the Nucleus Network group, which operates clinical trials and pharmacy services across the UK, Australia and the US. The role We're creating a new senior QA position in our Pharmacy GMP QA Division: Pharmacy QA Manager. You'll hold line management responsibilities for the QA Officer, delegated authority to review and approve specified GMP quality documents on behalf of the QP/Head of Pharmacy, and ownership of new equipment qualification, pharmacy facility management and validation projects, working alongside the Production Manager and EMO & Validation Coordinator and external contractors. This is a hands-on, independent role in a live GMP/GCP environment, not a desk-bound compliance function. You'll be closely involved in a major facility expansion at HMR and in the group-wide harmonisation work What you'll be doing -      Line managing the Pharmacy QA Officer and EMO& Validation Coordinator, including workload allocation, performance and development. -      Writing, reviewing and approving GMP quality documents (eg SOPs, Risk Assessments, Change Controls) under authority delegated by the QP/Head of Pharmacy. -      Leading, supporting and witnessing the installation, qualification (IQ/OQ/PQ) and validation of pharmacy equipment, including authorship of URS and validation protocols/reports, in coordination with the PM, EMO & Validation Coordinator and equipment contractors. -      Supporting the EMO & Validation Coordinator in the management of equipment/facilities (eg revalidation, servicing, review of EM reports etc) -      Working with the Head of Pharmacy/QP to maintain HMR's MHRA-licensed status. -      Participating in internal and external audits and regulatory inspections, and scheduling self-inspections. -      Reviewing GXP regulatory change and its implications for pharmacy. -      Developing and and maintaining the pharmacy QMS in line with regulations such as Annex 1 and ICH10. -      Scheduling and leading the Pharmacy Quality Review Meeting with the GMP QA Officer. What we're looking for -      A science degree (eg chemistry, biology, pharmacy, microbiology), with in-depth knowledge of both GMP and GCP. -      Knowledge of GAMP /CSV would be an advantage -      Experience writing high-level quality system documents such as validation protocols, URS and Risk Assessments. -      Experience participating in GMP audits, and the ability to operate independently. -      Excellent writing skills, strong attention to detail, and good organisational and time management skills. -      Advanced Microsoft Office skills, including advanced Excel (macros, VBA, complex formulas) and Word (creating templates, managing multi-page style sheets, and tracking changes). -      A proactive approach to problem solving and the ability to prioritise across competing demands. -      Line management or supervisory experience is an advantage; candidates tracking toward QP eligibility are encouraged to apply.   How to apply: Email your CV and a covering letter to careers@hmrlondon.com. In your cover email, please clearly state your aseptic experience.

To find out more about us, visit: www.gmp-pharmacy-london.com HMR Cumberland Avenue, Park Royal London NW10 7EW