Third Party Manufacturer QA Sr.Associate (TPM QA )

Abbott; Fatih; On-site; TRY 500,000 - 800,000; Full time

Job summary

Abbott in Istanbul is seeking a Senior TPM QA Associate to ensure quality and compliance across third party manufacturers within GMP-regulated operations. You will manage deviations, investigations, CAPAs, PQRs, stability programs, and audits, coordinating with internal teams and TPM partners.

The role requires a pharma-related degree and 5–7 years of QA/QC in GMP settings, strong documentation and English skills, and willingness to travel up to 40%.

Qualifications

• Bachelor’s degree in pharmacy, chemistry, chemical engineering or related scientific discipline.
• Minimum 5–7 years in QA/QC and/or pharmaceutical manufacturing in a GMP-regulated environment.
• Good knowledge of cGxP, ICH guidelines and national/international pharma regulations.

Responsibilities

• Accountable for quality and compliance performance of assigned TPMs, ensuring cGMP and QTAs.
• Lead quality risk management activities including deviations, investigations, change controls, CAPAs, PQRs, stability programs, and validation activities.
• Review and approve TPM quality documentation (MRs, Packaging Records, Validation/Reports, Stability Protocols, PQRs, CAPAs).
• Lead quality oversight of TPMs through metrics review, GEMBA visits, remediation plans, and continuous improvement.
• Coordinate audits, supplier qualification, regulatory inspections, tech transfers, and cross-functional projects.
• Provide risk-based recommendations and escalate quality/compliance issues to internal stakeholders and senior management.
• Support QTAs maintenance and Approved Supplier List; align with regional/global quality initiatives.

Skills

Quality Assurance

GxP compliance

ICH guidelines

CAPA management

Deviations & investigations

Validation & qualification

Process validation

Cross-functional collaboration

Report writing

English proficiency

Education

Bachelor’s degree in Pharmacy, Chemistry or Chemical Engineering

Tools

Microsoft Office

Job description

## Third Party Manufacturer QA Sr.Associate (TPM QA )Candidatar-se: Türkiye - İstanbul: Tempo Integral: Publicado hoje: 31166518Descritivo de Cargo## **Third Party Manufacturer QA Sr.Associate (TPM QA)****About Abbott**Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **The Opportunity**This position works at Istanbul location in the Established Pharmaceuticals Division that we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory. **What You’ll Do** * Accountable for the quality and compliance performance of assigned Third Party Manufacturers (TPMs), ensuring compliance with applicable regulations, cGMP requirements, Abbott Global/Regional Policies, and Quality Technical Agreements (QTAs).* Responsible for quality risk management activities including deviations, investigations, change controls, CAPAs, product complaints, Product Quality Reviews (PQRs), stability programs, validation activities, and product release support.* Review and approve TPMs quality documentation including Batch Manufacturing Records, Packaging Records, Validation Protocols and Reports, Stability Protocols and Reports, PQRs, change controls, deviations, investigations, exceptions, and CAPAs.* Lead quality oversight of TPMs through performance monitoring, quality metrics review, GEMBA visits, remediation plans, and continuous improvement initiatives.* Serve as the primary Quality contact for assigned TPMs, maintaining effective communication and strong working relationships with internal and external stakeholders.* Lead and coordinate quality activities related to GMP audits, supplier qualification, regulatory inspections, technology transfers, new product introductions, and cross-functional projects.* Drive investigation, resolution, and escalation of quality and compliance issues, providing risk-based recommendations and support to internal stakeholders and senior management.* Manage the preparation, approval, maintenance, and periodic renewal of Quality Technical Agreements (QTAs) and support the maintenance of the Approved Supplier List.* Support Regional and Global Quality Compliance initiatives and contribute to the enhancement of quality systems, processes, and regulatory compliance across the external manufacturing network.* Coordinate cross-functional teams and collaborate with Supply Chain, Regulatory Affairs, Operations, Procurement, Manufacturing, and other stakeholders to achieve business and quality objectives. **Required Qualifications** * Bachelor’s degree in pharmacy, Chemistry, Chemical Engineering, or a related scientific discipline.* Minimum 5-7 years of experience in Quality Assurance (QA), Quality Control (QC), and/or pharmaceutical manufacturing within a GMP-regulated environment.* Good knowledge of cGxP requirements, ICH guidelines, and applicable national and international regulations related to pharmaceutical products, raw materials, medical devices, food supplements, biologics, and biosimilars.* Sound understanding of pharmaceutical manufacturing processes, laboratory testing operations, quality systems, and validation/qualification activities, including Process Validation, Cleaning Validation, and Equipment Qualification.* Strong analytical, problem-solving, organizational, and follow-up skills, with the ability to manage multiple priorities and support the resolution of quality and compliance issues.* Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams and external partners.* Proficiency in written and spoken English, including technical documentation and report writing.* Proficiency in Microsoft Office applications.* Willingness and flexibility to travel domestically and internationally up to 40 % of the time. **Apply Now** Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.**The base pay for this position is**N/AIn specific locations, the pay range may vary from the range posted.Família de CargoOperations QualityDivisãoEPD Established PharmaLocalidadeTürkiye > Istanbul : Saray Mah Dr Adnan Buyukdeniz Cd UmraniyeLocalidades AdicionaisTurno de TrabalhoStandardViagemNot specified