Senior Third Party Manufacturer QA Associate (TPM QA)

About the role

Abbott's Established Pharmaceuticals Division in Istanbul is hiring a Senior Third Party Manufacturer QA Associate. The role is accountable for the quality and compliance performance of assigned third-party manufacturers (TPMs), covering cGMP requirements, Abbott policies and Quality Technical Agreements, and supporting quality oversight of external manufacturing.

Key responsibilities

• Ensure TPMs comply with regulations, cGMP requirements, Abbott policies and Quality Technical Agreements (QTAs)
• Handle quality risk management: deviations, investigations, change controls, CAPAs, product complaints, PQRs, stability programs, validation and product release support
• Review and approve TPM quality documentation such as batch and packaging records, validation protocols and reports, stability reports, change controls, deviations, investigations and CAPAs
• Monitor TPM performance through quality metrics, GEMBA visits, remediation plans and continuous improvement
• Serve as the primary quality contact for assigned TPMs and lead quality activities for GMP audits, supplier qualification, regulatory inspections, technology transfers and new product introductions
• Manage QTAs and the Approved Supplier List, and support regional and global quality compliance initiatives
• Coordinate with Supply Chain, Regulatory Affairs, Operations, Procurement, Manufacturing and others

Required profile

• Bachelor's degree in pharmacy, chemistry, chemical engineering or a related scientific discipline
• 5-7 years of experience in QA, QC and/or pharmaceutical manufacturing in a GMP environment
• Good knowledge of cGxP, ICH guidelines and applicable national and international regulations
• Strong analytical, problem-solving and communication skills; proficiency in written and spoken English
• Willingness to travel domestically and internationally up to 40% of the time

Required skills

• Understanding of pharmaceutical manufacturing, laboratory testing, quality systems and validation/qualification (Process Validation, Cleaning Validation, Equipment Qualification)
• Proficiency in Microsoft Office