3 months ago
We are currently looking for a QA specialist to join a fast-growing specialty pharmaceutical and biotechnology company. The company is at an exciting stage and major phase of growth with a multiple of products in the process of being launched out to the market. The role involves a QA specialist to fill a vacancy on a permanent basis to ensure that batch production complies with GMP standards. The basic functions include participating in GMP performance, ensuring that an appropriate level of product batch record reviews are carried out at partner sites regularly.
- Prepare and maintain Technical (Quality) Agreements with third party contractor manufacturing organisations (CMOs) so that roles and responsibilities between the contracted parties are clearly defined and implemented
- Ensure that an appropriate level of product batch record reviews are carried out at partner sites.
- Regularly review non-conformances e.g. process deviations, out of specification/trend results etc at the CMO to ensure that resulting investigations have identified the root cause(s), that suitable reports have been written and that corrective and preventative actions (CAPAs) have been implemented within suitable time periods.
- Participate in the internal audit (self-inspection) programme so that any gaps and deviations identified in systems and procedures are addressed by the relevant department
- Degree in Science related discipline or related field
- 3-5 years' industry experience in Quality Assurance
- Extensive knowledge of the Pharmaceutical industry
If interested contact firstname.lastname@example.org or +44 2921677066