4 months ago
Hamlyn Williams is currently working with a fast-growing a pharmaceutical company based outside of Edinburgh is looking for a QA Specialist to join their team on a permanent basis. This company is at a very exciting stage with major growth. As a result of this growth, they are actively looking to grow their quality assurance team with a QA Specialist role.
The role involves but isn't limited to:
• Ensure that an appropriate level of product batch record reviews is carried out at the CMO facilities, prior to the release of a product for sale and distribution
• Regularly review non-conformances e.g. process deviations, out of specification and trend results etc at the CMO to ensure that resulting investigations have identified the root cause(s).
• Ensure that all changes to GMP documents, processes, equipment and facilities are effectively managed through the CMO to ensure GMP and regulatory compliance.
• Ensure Product Quality Reviews have been carried out and that any trends have been identified and corrective and/or preventative actions implemented.
• Ensure that GMP stability programs are established, implemented and regular reports issued by the CMO(s).
If you are an experienced QA Specialist who is looking for a new opportunity this could be the perfect role for you.
Any questions, don’t hesitate to get in touch!