This global biopharmaceutical company is looking for a driven individual to join their Quality team in Cork. This is an 11 month contract.
The Quality Assurance associate is responsible for supporting site quality systems, manufacturing operations and inspection readiness.
- Ensure site preparation for GMP operations by supporting cross functional initiatives
- Review and approve electronic and paper production batch records
- Release Raw Materials for production
- Support Technology Transfer of a new product into the site including raw material and supplier qualification
- Review and approve Trackwise deviation and investigations reports, ensuring root causes have been identified and corrective action implemented
- Provide support as required: Document control, New or updates to relevant quality agreements, process and Cleaning Validation activates
The successful candidate will have:
- Bsc of Science degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological science, pharmacy)
- Minimum 3 years relevant experience in a cGMP regulated manufacturing environment, with exhibited knowledge and proficiency in Quality Assurance and Compliance
- Experience in supporting manufacturing operations, batch record review and deviation/CAPA is highly desirable
If you would like to discuss this role, reach out to Louise Whitty on 021 2359140 / email@example.com
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