Quality Assurance Auditor

2 weeks ago

Kent, United Kingdom Cranleigh Scientific Full time

A global pharmaceutical company requires a Quality Assurance Auditor to join its team on a 12-month contract. You will be responsible for reviewing batch documentation to ensure compliance with manufacturing standards and for Auditing manufactured and rawmaterial batches to the relevant standards. This is a late shift role, 14:00 - 22:00. Basic salary + Shift allowance.

**MAIN DUTIES**:
- Audit batch documentation packages for compliance prior to release of product for sale including the review and approval of QC results within Oracle.
- Conduct plant and QC inspections to ensure that procedures and practices are being adhered to when required.
- Review and generate production batch documentation of RP batches prior to release.
- Correct entry of appropriate data into the Oracle computer system for the release of batches for manufacture and subsequent approval for packing.
- Change status of raw material deliveries in the Oracle system as indicated by completed raw material data packages.
- Liaison with colleagues in other departments, share data and provide QA documents when required.
- Conduct GMP audits when required in line with the companies yearly audit requirements.
- Maintain FTR & FTQ data for management reporting and analysis.
**EXPERIENCE REQUIRED**
- Experience of working within a Quality Assurance environment.
- ISO9000 & cGLP/GMP experience or similar.
- Good attention to detail and the ability to maintain this in a pressurized environment.
- General awareness of Quality Assurance and Quality Management Systems.
- Able to communicate effectively across departments and at all levels.
- Computer Literate - Excel, Word etc
- Experience gained in the pharmaceutical industry.
- Auditing - possible accredited
- Lean Sigma / Continuous Improvement.
- Computer literate in Oracle.

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