Lead Quality Assurance Specialist

3 weeks ago


Liverpool, Liverpool, United Kingdom PE Global Full time
Position Overview

PE Global is seeking a Lead Quality Assurance Specialist with pharmaceutical expertise for a contract role with a prominent multinational pharmaceutical organization.

Key Responsibilities

  • Provide quality assurance oversight for designated external suppliers and third-party manufacturers, ensuring compliance with established quality standards and regulatory requirements.
  • Serve as the Authorized Person for product release, including managing material status changes in the relevant systems.
  • Evaluate and approve production deviation reports from third parties, ensuring accuracy and completeness, and assess proposed corrective and preventive actions (CAPA).
  • Review and analyze external customer complaints within the global complaint management system, ensuring timely and accurate investigation evaluations and CAPA assessments.
  • Maintain qualification status for batch record reviews of contract manufacturers.
  • Oversee and drive the CAPA system for the region.
  • Utilize established quality assurance systems to monitor external suppliers and contractors, ensuring that quality agreements are up-to-date, supplier risk assessments are conducted regularly, and Product Quality Reviews (PQR) meet established criteria.
  • Monitor third-party key performance indicators (KPIs) to proactively identify and report any compliance issues that may affect product supply.
  • Analyze Third Party Product Quality Reviews (PQR) for quality trends at the supplier level, implementing necessary corrective actions and providing comprehensive summaries for management review.
  • Request and ensure timely annual Pharmacovigilance statements for PQRs.
  • Assist quality assurance management with any quality-related issues.
  • Support the quality assurance business unit with market releases.
  • Represent the quality function and provide expertise in assigned projects and expert teams.

Qualifications

  • Degree in a scientific discipline such as Chemistry, Biology, Pharmacy, or Pharmaceutical Engineering.
  • Experience in quality operations within a Good Manufacturing Practice (GMP) environment.
  • Strong understanding of regulatory requirements.
  • Proficient in office software tools (e.g., Word, Excel, SAP).
  • Experience in managing customer complaints.
  • Familiarity with negotiating quality assurance contracts.
  • Experience with quality assurance systems that facilitate third-party management.
  • Experience working in a global corporate environment.

Interested candidates are encouraged to submit an updated CV.

***Please note that the organization cannot provide visa sponsorship; candidates must possess the appropriate visa to work in the UK.***



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