Senior Quality Assurance Manager with QP status
Jason Johal at CK Science is currently recruiting for a Senior Quality Assurance (QA) Manager with Qualified Person (QP) status to join a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. This role is based in London and is offered on a full time permanent basis.
The primary role of the Senior QA Manager is to perform routine quality assurance tasks and activities ensuring compliance with all regulatory and corporate requirements and to act as EC/EEA Qualified Person and UK Responsible Person as required. In addition this position will assist in the development, organization, and execution of the Quality Assurance Management system of the European group within the International and Global Quality Organization which will ensure product quality and compliance with all regulatory and corporate requirements for company Products within Europe and Rest of World Markets as applicable.
Your main responsibilities in this role will be to:
- Manage and oversee for assigned Contracted Service Providers quality assurance activities to ensure product is manufactured, packaged, tested, released and distributed in compliance with all regulatory and corporate requirements
- Approve master production/packaging records
- Recommend quality related improvements to contractors
- Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.
- Act as Qualified Person / Responsible Person as per requirements of company licenses and execute Qualified Person functions in accordance with Professional Code of Conduct of the Joint Professional Bodies and as per Art. 48 and Art. 51 of the EU Directive 2001/83/EC
- Act as Responsible Person as per requirements of company licenses and ensure that the conditions of the wholesale dealer's license are met, and the Rules and Guidelines of Good Distribution Practice are complied with
- Manage change control requests
- Process product complaints
- Review, edit, negotiate improvements to, and approve contractor documentation
- Process validation protocols and reports
- Transfer validation protocol and reports
- Investigations, Deviations, OOSs
- Conduct review and approval of non-routine quality investigations related to batch deviations, batch disposition, validation activities, stability results, critical quality complaints, returns and other quality systems for assigned products
- Develop and maintain Reference Master Files
- Participate in self inspections as appropriate
- Participate in external audits of contractor manufacturers and distributors as assigned.
- Review and provide recommendations on policies and standards, as assigned
- Support GMP/GDP site inspections, as assigned
- Maintain compliance with personal training requirements
You are required to have the following qualifications, skills and experience:
- Eligible to act as Qualified Person within EC/EEA
- Extensive demonstrated pharmaceutical quality experience, including audit, batch record review, change control, complaint handling and investigations experience
- A thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly)
- Demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance • Current cGMP knowledge as well as having a good understanding of GCP and the ability to support the Clinical teams across the company
- A Degree or equivalent in a scientific or technical discipline
If you are successful will be joining a company that values their passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries (and growing), they are looking for talented people to grow their business, advance their science and contribute to their unique culture
For more information or to apply for this Senior QA Manager with QP status position please contact Jason on +44 (0)1438 723 500 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST31858 in all correspondence.