- Review all documentation associated with batch release to ensure GMP compliance.
- Verify the labelling of the raw material, packaging components, bulk and finished product.
- Ensure the follow-up of the necessary corrective actions & preventative actions implemented in consequence of a quality failure
- Perform investigations, and ensuring a follow-up, following discrepancy, failures and external complaints.
- Participate in KPI meetings to assist the batch release process.
- Review the GMP documentation eg, SOPs, reports, methods, specifications, validation protocols, quality contracts etc.
- Perform the Annual Product Review (data collection, graphic analysis…)
- Writing and reviewing QA department procedures and reports eg. protocols, SOPs, environmental reports etc.
- BSc in Science or related area
- Minimum 3 years' pharmaceutical experience in a regulated environment would be preferable.
- Knowledge of GMP. Good organisation skills and time management. Analytical approach to problem solving. Word, Excel
- Teamwork, flexibility, information gathering, execution, problem analysis & initiative
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists