Quality Assurance Associate - #2067933

PE Global are currently recruiting for a Quality Assurance Associate on behalf of a leading global pharmaceutical client based in Speke, Liverpool.

Contract duration: 12 months

Location: Speke (3 days on site, 2 days work from home)

Rate: £19.23 and £25.64 per hour.

Quality Assurance Job Responsibilities:

• To perform QA oversight on assigned external suppliers and third parties manufacturing products ensuring that the delivered products comply with 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 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 overview and request timely annual Pharmacovigilance statements for PQRs.
• 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 final review.

Requirements

• Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering;
• Experience in quality operations in the GMP environment;
• Excellent command of English, other languages are an asset;
• Knowledge and understanding of regulatory requirements;
• Good knowledge in office tools (e.g. Word, Excel, SAP).
• Working experience within a global, ideally pharmaceutical, organization advantageous.

Interested candidates should submit an up to date CV.

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