My client is looking for a QA Specialist to join their team, on-site in Co. Cork.
- Review GMP documentation.
- Write & review QA Department Procedures & reports as well as reviewing & approving other departmental procedures & reports.
- When required, internal auditing of FLI Departments & external auditing of Material & Service Suppliers.
- Assist in the preparation & review of the QA department reports & metrics.
- Participate & follow up on any audits and/or inspections carried out on site.
- Prepare & assist in the presentation of GMP training programmes.
- Ensure QA activities are executed in line with in-house procedures & in compliance with the requirements of CGMP.
- Support supplier activities – risk management, qualification etc are executed in line with company procedures & compliance with requirements of CGMP.
- Review all documentation associated with batch release to ensure GMP compliance.
- Verifying labelling of raw material, packaging components, bulk & finished products.
- Participate in KPI meetings to help assist with the batch release process.
- Level 8 in a Science related discipline.
- 3+ years of experience within a highly regulated environment.
- Solid dose experience.
- Knowledge of GMP.
- Analytical approach to problem-solving.
For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / firstname.lastname@example.org
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