QA Manager - Manufacturing - Pharmaceuticals - GBP35k-GBP40k -Berks

35000.00 - 40000.00 GBP Annual + GBP35000 - GBP40000/annum
26 Sep 2017
24 Oct 2017
Contract Type
Full Time
QA Manager - Manufacturing - Pharmaceuticals - GBP35k-GBP40k -Berks - QMS - CAPA - API - Solid Dose - ICH - Batch Review

A growing pharmaceutical manufacturer requires a QA Manager. You will be responsible for the development, operation and management of integrated Quality Systems and also build your own QA team. You must have proven experience as a quality manager within another pharmaceutical manufacturing business.

Role Summary

The QA Manager will be responsible for tracking, trending, reporting Key Quality Performance Metrics and providing continuous Improvement of the Quality Management System, to assure alignment with necessary Directives.


*Responsible for development, operation and management of integrated Quality Systems
*Promote the development of a company-wide culture of quality assurance and implementing key elements related to the quality system
*Maintain knowledge of existing and emerging regulations, standards, or guidance documents.
*Ensure high level quality throughout the entire supply chain
*Partner with Operational activities with focus on both quality and on-time-delivery
*Lead Quality complaint investigations, deviations, non-conformances, out of specifications, trending using quality system tools to identify root cause and ensure timely closure for identified Corrective and Preventative Actions.
*Lead and continuously improve Site Quality Management System and assure compliance with applicable regulations.
*Manage quality elements of solid oral dosage products from API through final packaging including management of CMOs.
*Developing and implementing risk based approaches to the batch review and disposition process.
*Accountable for QP batch certification and release process.
*Develop and maintain the Validation Master Plan and lead the site in meeting the plan.
*Provide technical expertise during validations, qualification protocols, risk/impact assessments, traceability.
*Coordinate validation projects for equipment, processes, facility, utilities, cleaning, and computer systems.

Required Skills

*Bachelor's degree preferably in pharmaceutical sciences/ Chemistry
* Significant experience within Quality Assurance and/or Compliance.
* Proven experience of leadership and management experience in Quality functions.
*Extensive knowledge in cGxPs, ICH and other pharmaceutical regulations