Due to continued growth, an established pharmaceutical company has an exciting opportunity for a Quality Assurance Specialist. As a senior member of the team you will provide support across all QA functions and be responsible for leading and following-up on investigations. You must have significant experience working in a similar QA position within the pharmaceutical industry.
- Handling of day to day activities related to operations and quality systems, this includes but is not limited to, the handing of complaints, deviations, change controls, technical agreements, stability programs (monitoring and assessment), product specification files, batch documentation, batch release, Product Quality Reviews.
- Review and approval of masters and technical documentation related to validation, manufacturing and testing.
- Lead and follow up on investigations and CAPA’s implementation and effectiveness
- Liaising with CMOs (Contract Manufacturing Organisations) and other contractors inside and outside of the EU (manufacturing, testing, warehousing, transportation)
- Qualification and monitoring of suppliers and contractors, and participate in self-inspection activities
- Support the QA department in maintaining the QMS in good order
- Participate in the batch release process
- Liaise and communicate with the customers on Quality related topics
- Support other internal departments as and when required
- Enforcing the compliance to European GxPs (e.g. MHRA orange guide) and Marketing Authorisation Dossiers
- Degree in life sciences (minimum bachelor degree, ideally masters or above)
- Post qualification experience of working in a similar QA position
- Strong knowledge and understanding of the pharmaceutical industry guidelines including but not limited to the Eudralex volume 4 and the ICH guidelines.
- Previous active experience of project management would be an advantage
Salary £30k - £33k
Job Ref: 5613