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Position: QA Specialist – External Manufacturing (EMEA)
Location| Full-Time | Permanent
Are you experienced in GMP quality operations and passionate about ensuring third-party manufacturing meets the highest standards? We are seeking a Quality Assurance Specialist to support third-party operations across the EMEA region, ensuring products are consistently produced and released in full compliance with regulatory and internal quality standards.
Key Responsibilities
* Provide QA oversight for assigned third-party manufacturers, ensuring compliance with internal quality standards and applicable legal requirements.
* Monitor and evaluate third-party KPIs to proactively identify and escalate potential compliance risks that could impact product supply.
* Assess customer complaints via the global complaint management system, including evaluating root cause investigations, product impact, trends, and CAPA proposals.
* Review deviation reports submitted by third parties to ensure completeness and quality, with a focus on root cause analysis, trending, and corrective/preventive actions.
* Evaluate batch release documentation from external suppliers and, when required, support the batch release process, including status updates in SAP.
* Analyze Third-Party Product Quality Reviews (PQRs) for supplier-level quality trends and corrective actions, providing clear summaries to QA leadership.
* Coordinate and request annual Pharmacovigilance statements for inclusion in PQRs.
* Maintain oversight of QA systems related to third-party management, ensuring quality agreements are current, risk assessments are up to date, and PQRs meet expectations.
* Support quality-related initiatives and represent the QA function on cross-functional teams and assigned projects.
Requirements
* Scientific degree in Chemistry, Biology, Pharmacy, or Pharmaceutical Engineering (or equivalent).
* Hands-on experience in GMP-compliant quality operations, preferably within pharmaceuticals or life sciences.
* Strong knowledge of regulatory requirements and global quality standards.
* Proficient in Microsoft Office tools and SAP.
* Excellent written and spoken English; additional languages are an advantage.
Preferred Qualifications
* Experience in managing customer complaints and CAPA processes.
* Familiarity with QA agreements and third-party quality management systems.
* Exposure to working in a complex, global organization and cross-functional teams.
This is a fantastic opportunity to play a vital role in safeguarding the quality and compliance of
externally manufactured pharmaceutical products across the EMEA region. If you thrive in a fast-paced, collaborative environment and are passionate about quality assurance, we’d love to hear from you.
Apply now to help drive quality excellence in global pharmaceutical operations.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance and Manufacturing
* Industries
Pharmaceutical Manufacturing
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