Posted on Feb 2, 2019 by Hays Specialist Recruitment Limited
QA Manager, Validation, Audit, CAPA, CMO, GMP, GxP, API, QMS, DMS, Risk management
Your new company
A leading biopharmaceutical group, this company specialises in innovative medicines for oncology, neuroscience and rare diseases. With almost a century of heritage, their products give them a presence in over 100 countries with a commercial presence in more than 30 countries globally. With heavy investments into their R&D, they are one of the world's leading biopharmaceutical companies when looking at oncology sales alone.
Your new role
As a QA Manager in this role, you will be required to develop and maintain GxP Quality Management Systems with CMOs and Testing Laboratories, ensuring compliance. Quality Auditing with use of CAPAs will also constitute a large portion of the position, as well as the review and sign off of process and cleaning validation and the disposition of Finished Products, APIs, Raw Materials and components. You will be leasing upward with the Director of Quality to develop a business aligned Quality strategy. Furthermore, risk management and identification will be carried out, followed by immediate remediation and mitigation in line with company systems and products.
What you'll get in return
To be successful in this position you will need a thorough understanding of cGMP guidelines and manufacturing experience cultivated through years of experience. Experience of internal and external auditing, CAPA and deviation management and risk assessment as well as biotech and aseptic manufacturing processes will be essential. A familiarity with EQMS (Trackwise) and EDMS (Documentum) systems is also required. Furthermore, a relevant degree or equivalent is a must have and a Master's in a Life Sciences Discipline would be ideal.
What you need to do now
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