Senior Quality Associate

3 weeks ago

United Kingdom Planet Pharma Full time

Job Title: Quality Associate

Location: Liverpool, UK (onsite weekly)

Type: Contract (12 months)

Functions, Duties, Tasks:

  • Perform QA oversight on assigned external suppliers and third parties manufacturing products and ensuring that the delivered products comply with quality standards and legal requirements.
  • Act as Authorized Person for the release of products for shipment including material status change in SAP.
  • Review and approve production deviation reports provided by third parties for correctness and completeness including the assessment of suggested CAPA.
  • 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.
  • Maintain a batch record review qualification status of contract manufacturers.
  • Monitor and to drive EEM-EMEA CAPA system.
  • 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.
  • Monitor third party KPI’s to proactively detect and notify QA management any compliance issue on supplier level that would risk supply of products.
  • 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.
  • Overview and request timely annual Pharmacovigilance statements for PQRs.
  • Support QA management in any quality related matter.
  • Represent the quality function and to give QA support in assigned projects and expert teams as SME.

Minimum Qualification (education, experience and/or training, required certifications):

  • 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.

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