* Our client is a European pharmaceutical company that manufacture braded and generic pharmaceutical products for the global market
* They have a small team based in Central London consisting of Quality, Regulatory Affairs, Commercial, Sales and Accounts
* This role offers excellent progression with expansion of the company
Our client is looking for a QA Manager to join their office in Central London on a permanent basis. Responsibilities include;
* Oversee & support UK batch release activities in accordance with 2001/83/EC (Human medicines directives) & UK SI 2012:1916 (UK Human medicines regulation)
* Support of External audits of existing and potential suppliers
* Ensure Compliance with Annex 16 of the EU Guide to Good Manufacturing Practices relating to batch certification by a QP
* Review & manage Deviations, Change controls & complaints
* Review and approve technical agreements & annual products quality reviews received from third party manufacturers
* Assist in regulatory inspections and client audits as required
* To provide QA support for all third-party manufacturing operations
* Ensure all products released for sales are GDP compliant
* Management of site licenses to include MIA, WDA (H) & CD license
* To support with both in house and third-party audits both within and outside the EU so a significant degree of travel will be required
* The checking and approval of master documents for manufacturing, packaging, process amendments and other quality documents as appropriate.
* To ensure process and equipment validation by third parties is carried out in accordance with agreed schedules
* To accompany external auditors (MHRA) and other regulatory personnel during GMP audits
* To assist with development and improvement of the quality management system
* Management of annual training requirements for all staff to include GMP, GDP, PV and new starter training.
* To liaise closely with the manufacturing site in Switzerland and other third party CMO's
* To provide support to other departments for the introduction and development of new product launches ensuring compliance and resolution to all quality related issues
* To provide assistance with the preparation of technical agreements, documentation, compliance and compatibility with GMP and site requirements
* To liaise directly with client companies and regulatory bodies concerning QA issues.
* To raise any potential GMP risks to Senior Management.
* To support the UK Regulatory affairs manager with local regulatory activities and compliance (good understanding of the regulatory processes desirable)
* 5 - 10 year's experience within QA in the pharmaceutical market
* Excellent working knowledge of GMP/GDP regulations and the ability to support and conduct accurate audits
* Proactive leadership, excellent communication and analytical skills
* Ability to interpret MHRA and other regulatory guidelines/legislation
* Some travel will be required for manufacturing purposes
What should you do next?
This QA Manager is one not to be missed; it encompasses the opportunity work for an exciting, forward thinking company! To discuss further, please submit your current CV.
Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.