Lead Quality Assurance Specialist
3 weeks ago
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, along with assessing 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 EEM-EMEA region.
- Utilize established quality assurance systems for oversight of 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 expectations.
- Monitor third-party key performance indicators (KPIs) to proactively identify and report any compliance issues that may jeopardize 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 final reviews.
- Request and ensure timely annual Pharmacovigilance statements for PQRs.
- Assist quality assurance management with any quality-related issues.
- Support quality assurance business units 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 knowledge 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.
- Previous experience in a global organizational setting.
Note: Candidates must possess the appropriate visa to live and work in the relevant location.
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