North East, England
£30,000 - £35,000
This role is an opportunity for an experienced QA Officer to join an enthusiastic analytical team in the OQ Department of a leading UK-based Pharmaceutical company.
I am currently recruiting for an experienced Quality Assurance Officer, in this position you will be working as part of the OQ Department and you’ll be responsible for batch sequencing activities on API based products. You will also perform other quality assurance related activities including reviews, approvals, audits etc to cGMP standards. The suitable candidate must have experience working with Batch Release in an API manufacturing environment.
Further responsibilities of the role include, but are not limited to, the following:
- OQ approvals of PRSs and changes in process, analytical and engineering procedures
- Perform OQ assessments of Decision paths, non-conformance and deviations
- Review cGMP clearouts
- Ensure plant is cGMP compliant
- Maintain OQ systems covering change control
- Coordinate validation activities
- Approve master PRSs
- The successful candidate must have considerable experience working in a QA role
- Candidate must have worked on batch release, BMRs etc.
- Candidate must have significant experience working in API manufacturing
- Candidate must have a minimum of an honours degree in Chemistry
- Excellent organisational skills
- Excellent communication skills