Quality Assurance

PE Global are currently recruiting for a Senior Quality Associate for a contract role with a leading multinational Animal health client, based in Speke – Liverpool.

To support third party quality operations at EEM EMEA and ensure that third party products are produced and released according to our client’s requirements. To operate and maintain quality systems which monitor the compliance of third-party manufacturers and products.

Responsibilities

• To perform QA oversight on assigned external suppliers and third parties manufacturing product and ensuring, that the delivered products comply with the quality standards and legal requirements.
• To monitor third party KPI’s to proactively detect and notify to QA management any compliance issue on supplier level that would risk supply of products.
• To review and assess external customer complaints in the global complaint system, including Root Cause Investigation correctness, product impact assessment, trend/recurrence evaluation, and proposed CAPA assessment, within the due time periods.
• To review and assess Third-Party deviation reports for correctness/completeness, including Root Cause Investigation, assessment of product impact, trending/recurrence evaluation, and suggested CAPA.
• To review batch release documentation provided by third parties to support or act as Authorized Person for release of products for shipment including material status change in SAP.
• To review Third Party Product Quality Reviews (PQR) for quality trends on supplier level including the implementation of necessary corrective actions and provide the Third-Party QA Manager with a conclusive summary as base for his final review.
• To overview and request timely annual Pharmacovigilance statements for PQRs.
• To utilize established QA systems for the QA oversight of external suppliers and contractors and ensure that relevant quality agreements are current and in place, supplier risk assessments are periodically performed and Product Quality Reviews (PQR) meet expectations.

Requirements

• Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering.
• Experience in quality operations in the GMP environment.
• Knowledge and understanding of regulatory requirements.
• Good knowledge in office tools (e.g. Word, Excel, SAP).
• Experience in customer complaint handling.
• Experience in the negotiation QA contracts.
• Experience in QA systems that support Third Party management.
• Working experience within a global organization.

Interested candidates should submit an updated CV.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***