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Senior Quality Associate

3 months ago

Liverpool, Liverpool, United Kingdom Cpl Healthcare Full time

Senior Quality Associate

Speke

12 Month Contract

£19.23 to £25.64

Cpl Life Sciences are partnering with a large global healthcare company recruiting for an experienced Quality Associate To support third party quality operations across EEM EMEA and ensure that third party products are produced and released according to the clients requirements. To operate and maintain quality systems which monitor the compliance of third party manufacturers and products.


• To perform QA oversight on assigned external suppliers and third parties manufacturing products for the client and ensuring that the delivered products comply with clients quality standards and legal requirements.


• Act as Authorised Person for the release of products for shipment including material status change in SAP.


• To review and approve production deviation reports provided by third parties for correctness and completeness including the assessment of suggested CAPA.


• To review and assess external customer complaints in the clients globalcomplaint system including the evaluation of the complaint investigation for correctness and an assessment of proposed CAPA within the due time periods.


• To maintain a batch record review qualification status of contract manufacturers.


• To monitor and to drive EEM-EMEA CAPA system.


• To utilise 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.


• Monitor KPI's to proactively detect and notify QA management any compliance issue on supplier level that would risk supply of products.


• To overview and request timely annual Pharmacovigilance statements for PQRs.


• To support QA management in any quality related matter.


• To support QA BU Switzerland with releases to the market.

Essential skills and experience


• Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering.


• Experience in quality operations in the GMP environment.


• Excellent English, other languages are an asset.


• Knowledge and understanding of regulatory requirements.


• Good knowledge of office tools (e.g. Word, Excel, SAP).

Please apply within or send your CV to for more information.

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