Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from Planet Pharma

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

Referrals increase your chances of interviewing at Planet Pharma by 2x

Sign in to set job alerts for “Quality Assurance Associate” roles.

Liverpool, England, United Kingdom 3 days ago

Chester, England, United Kingdom 2 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.