JOB DESCRIPTION:
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/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EPD Established Pharma
LOCATION:
Türkiye > Istanbul : Saray Mah Dr Adnan Buyukdeniz Cd Umraniye
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable