Entrust People are recruiting for a QA Officer top work with one of the world's leading suppliers to the pharmaceutical and biotech markets. Reporting to the QA Manager this role is responsible for providing systemic and administrative support to the QA Department. The ideal candidate will therefore have a background in QA auditing and document review and control.
Key responsibilities and accountabilities:
1. Support to the site QMS.
2. Review of SOP’s.
3. Review, approval and issue of laboratory documentation.
4. Control and maintenance of GMP documentation.
5. Implementation, routine review and approval of change controls.
6. Involvement with investigations arising from deviations.
7. Assist with both internal and external audits and follow up of actions arising from them as required.
8. Support the supplier assessment program.
Person Profile: QA Officer
The ideal candidate will be:
1. Results oriented with a positive outlook and clear focus on high quality output.
2. Able to demonstrate good written and verbal communication skills.
3. Able to get on with others and be a team player, but be equally comfortable working independently.
4. Attention to detail.
5. Reliable, tolerant and dependable.
6. Comfortable dealing with senior managers, external auditors and suppliers.
7. Willing to learn from others.
8. Able to work in a fast, stimulating environment.
Flexible and able to work extended hours when required.
Specific Job Skills:
- Experience of working in a similar role within a GMP environment.
- Experience of document review and control.
- Able to communicate effectively with people at all levels in a Company.
- Able to write clear, concise reports.
- QA experience within a GMP environment.
- Audit experience, MHRA/FDA
- A degree or equivalent in Chemistry, Pharmacy, Biology or general science.
Computer skills: Must be competent in the use of MS Office, particularly Excel and Word,
outlook and internet;
Literacy and Numeracy: Must be competent in generating documents and writing reports both for internal use and for customers/clients. Must be numerate. A knowledge of Trackwise® QMS software would be advantageous.
Business Presentation Skills: Must be able to give clear oral presentations.