Quality Assurance Manager - Generics, Pharmaceutical

We are currently recruiting for a Quality Assurance Manager to join a Generics Pharmaceutical business in the London / Hertfordshire area. This is a hybrid role, working a minimum of 3 days per week in the office.

About the business you are joining:

Our client is a growing Pharmaceutical business who provide generics into the primary and secondary care sectors in the UK. Benefitting from a highly experienced leadership team, the business has really good partnerships and has established a very strong and reputable brand within the industry. At the same time, the business is constantly looking at growth opportunities, so you must be prepared to roll your sleeves up and play an active role in contributing to the future success. The culture within this business is great too - it is dynamic, fast-paced and very collaborative, so we are looking for individuals who thrive in such environments.

About the Quality Assurance Manager role:

The Quality Assurance Manager role is responsible for supplier qualification, oversight and assessment of GMP activities performed at suppliers' manufacturing sites, confirming that the storage and transport of products is compliant with GDP, and that all customers are vetted. In addition, the Quality Assurance Manager role involves QA review of batch records and transportation documents and coordinates/reviews QC testing to ensure all finished products meet applicable GxP and associated requirements and regulations. It will be essential for the Quality Manager to work as a key point of contact for Quality, coordinating correspondence with suppliers and customers to ensure timely provision of information needed for batch release and to demonstrate continued compliance.

The key responsibilities for the Quality Assurance Manager role will involve the following:

• Maintenance of the registers and folders of supporting documentation
• Investigation of Deviations and Complaints, raising and management of CAPA
• Initiation and management to closure of Change Controls, CAPA, Supplier Complaints
• Onboarding of suppliers and customers, Bonafide’s and annual requalification
• Oversee third-party logistics providers (3PLs), ensuring distribution practices align with GDP requirements
• Maintenance of Supplier Risk Matrix and Training Matrix
• Management and completion of supplier and customer queries
• Management of QA inputs to QTAs, TAs and SLAs
• Assessment of Route Risk Assessments and creation of Supply Chain maps
• Management of returns and stock destruction
• Updating procedures by due date or before as improvements identified
• Trending of QMS metrics, creation of reports and hosting Quality Review Meetings
• Management of QMS to maintain an ‘audit-ready’ status
• Management of any recall activities including mock recall
• Lead Self-Inspections, and adhere to self-inspection schedule at all times
• Conduct external audits as required
• Communication with UK testing labs and warehouse/distribution sites to ensure readiness for receipt of product/samples for testing
• Authoring of PQRs and other annual reviews
• Initiation and driving to completion Continuous Improvement initiatives
• Support timely QP and RP/RPi release by collating, reviewing, completing, and filing required documents
• All batch documents including BMR, BPR, CoA, and CoC are reviewed to ensure alignment with the Product Compliance Summary (PCS), Dossier and/or Process Validation Report or Protocol as appropriate, and highlighting concerns to QP
• Ensure that the artwork of the QC samples aligns with the artwork parameters mentioned in the Product Compliance Summary (PCS)
• Review all transportation documents including journey details and temperature logger data to ensure compliance with storage conditions, route risk assessments, Supply Chain Map, etc.
• Retain all electronic and hard copy documentation in compliance with procedure
• Accurate and full completion of all forms in line with the above reviews

The ideal candidate for the Quality Assurance Manager role will have the following:

• A degree-level qualification in a relevant discipline and 5+ years’ QA experience in a Generics Pharmaceutical environment
• A proactive approach to Quality Assurance, and enjoys working in a collaborative environment
• You will ideally be an MHRA approved Responsible Person (RP)
• Demonstrable knowledge of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
• Comfortable leading a small, but growing QA team