- Assist with the development and implementation of Quality Systems, processes and procedures.
- In conjunction with QA Manager, the co-ordination of Quality defects and Recalls.
- Oversight of Product Quality Complaints and Change Control processes.
- Responsible for all QA training requirements.
- Review and approval Product Quality Reviews
- Investigation of site related complaints at affiliates and third party manufacturers.
- Manage relationships with affiliates, partners and vendors for quality related activities.
- Provision of guidance to affiliates, partners and vendors on quality related matters.
- Review and closure of all APTL deviations and CAPA.
- Degree in a science discipline. E.g. BSc or equivalent.
- Minimum 5 years at Leadership level is desirable
- Pharmaceutical experience required
- A thorough understanding of Quality Systems and cGMP’s.
- Formal management training is desirable.
- Quality Management systems development and implementation.
- Quality Assurance and Risk Management experience.
- Experience with and a fundamental understanding of European GMP’s