Senior Quality Associate
An exciting opportunity has arisen for a Senior Quality Associate to support third party quality operations and ensure that third party products are produced and released. This role is based in Liverpool and is a fantastic opportunity to work at this company.
- To perform QA oversight on assigned external suppliers and third parties manufacturing products, ensuring, that the delivered products comply with legal requirements and quality standards.
- Support and provide Quality input for qualification and validation activities at Third Parties and support product launches.
- Manage and support change control activities with Third Parties.
- 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 global complaint system including the evaluation of the complaint investigation for correctness and an assessment of proposed CAPA within the due time periods.
- 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) meets expectations
Skills and Requirements
- Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering;
- Experience in quality operations in a GMP environment;
- Excellent command of English, other languages are an asset
- Knowledge and understanding of regulatory requirements;
- Very good knowledge in office tools and SAP (e.g. Word, Excel)
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.