Deputy QA Manager - Pharmaceutical
A successful contract laboratory is seeking an experienced and enthusiastic individual to join their Quality Assurance team. As a senior member of the team you will be responsible for leading and hosting audits and ensuring quality processes are investigated. You must have significant experience in Quality Assurance with excellent knowledge of GMP, ideally gained within the pharmaceutical industry.
Requirements and responsibilities -
- Proven track record and experience of GMP quality management systems.
- Knowledge of GLP and GCP regulations.
- Extensive experience in the creation, review/approval of deviations, OOS investigations and CAPA.
- Experience of CRO's and contract laboratories.
- Experience in:
- performing internal audits
- hosting client and regulatory audits
- managing customer complaints
- change control processes
- the review/approval of validation protocols and reports
- the use of an electronic quality management system
- quality metric trending, root cause analysis and problem solving
- quality/service agreement review
- An appetite for continuous improvement initiatives
- GxP - GLP - GCP - Deviations - CAPA - CRO's - Audits - Regulatory - Validations - QMS
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