QA Manager - Biotech - Berkshire - £Competitive
Our client is a global, market leading biotech company that manufacture and distribute treatments for oncology, neurosciences and rare diseases therapy areas.
Our client is looking for a QA Manager to join their External Manufacturing team in Berkshire! The ideal candidate will be highly experienced with the potential and drive to move into a Director position within the next 2 years. Responsibilities include;
* Deploy and maintain GxP Quality Management Systems with CMOs and Testing
* Laboratories to ensure compliance with regulations and inspection readiness at all times.
* Deploy and maintain a Quality Auditing capability with use of CAPAs to identify and track required improvements.
* Ensure that critical quality issues are reported to company management using the Global Quality alert process.
* Review and sign-off of master production, process validation and cleaning validation documentations provided by CMOs.
* Carry out the disposition of Finished Products, APIs, Raw Materials and Components when required.
* Identify and implement opportunities to simplify EMO business processes including sampling, testing and data generation.
* Support initiatives to meet or exceed Quality objectives. Contribute to continuous improvement planning and execution.
* Contribute to the deployment of the Global Technical & Quality roadmap for External Manufacturing
* MSc in a Life Sciences discipline
* 7 years hands-on experience gained in both Quality Assurance and Quality Control departments
* At least 3 years in a Supervisory position
* Thorough knowledge of cGMP guidelines gained through practical experience of
supporting cGMP manufacturing operations.
* Extensive experience of Internal & External Quality auditing, CAPA management,
deviation management & risk assessments. Preparation for FDA and EMA inspections
* Knowledge of biotech and aseptic manufacturing and processes, and product testing
* Familiarity with LIMS, EQMS (Trackwise), EDMS (Documentum) and EBR (Syncade) or
equivalent Quality systems.
What should you do next?
This QA Manager role is one not to be missed; it encompasses the opportunity to develop a strong QA career within a global, reputable biotech 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.