Zentiva Ankleshwar Invites Applications for QA Specialist Role in External Supply Operations Quality (ESO Quality) – Apply by October 20, 2026
Pharm'Up 
Zentiva, a leading European producer of high-quality affordable medicines, has announced a recruitment opportunity for a QA Specialist at its manufacturing facility in Ankleshwar, India. The company, which serves patients across Europe and beyond with a dedicated team of over 4,700 people, operates major production sites in Prague, Bucharest, and Ankleshwar.
This position is within the ESO Quality (External Supply Operations Quality) department. The successful candidate will be responsible for the quality lifecycle management of an assigned portfolio of subcontracted products and will provide independent Quality Assurance oversight for these products and their suppliers.
Key Responsibilities
The QA Specialist will play a crucial role in ensuring compliance with the Quality Management System (QMS), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other regulatory requirements. The primary responsibilities include:
- Operational Quality Management: Managing routine deviations, complaints, and related Corrective and Preventive Actions (CAPAs) independently. This includes conducting Root Cause Analysis and following up on agreed-upon actions.
- Documentation Review: Assessing change controls and their quality impact, reviewing GMP manufacturing documentation, analytical data, Certificates of Analysis (CoAs), Certificates of Compliance (CoCs), and relevant batch documentation. The role also supports batch release decisions.
- Supplier Quality Management: Assessing the compliance of assigned third parties, suppliers, and products. This involves reviewing supplier quality documentation, supporting supplier management activities, and preparing/maintaining Quality Agreements.
- Compliance and Auditing: Independently applying GMP, GDP, ICH, and other regulatory requirements. The QA Specialist will prepare for and participate in external supplier audits, internal audits, and inspections, as well as review audit reports and follow up on agreed actions.
- Lifecycle Support: Providing QA support for product launches, transfers, and lifecycle activities, including collecting and independently reviewing Product Quality Reviews (PQRs) and stability data.
- Risk Assessment: Conducting routine Quality Risk Assessments and identifying potential Data Integrity risks for escalation.
- Cross-Functional Collaboration: Monitoring Quality KPIs, analyzing data, supporting quality decisions, and communicating effectively across functions and with external partners.
Candidate Profile & Qualifications
To be considered for this position, applicants must meet the following criteria:
- Educational Background: A university degree in Pharmacy, Chemistry, Biology, or a relevant Life Science.
- Required Knowledge: Strong knowledge of pharmaceutical GxP regulations, Quality Systems, and GDP principles (EU GDP Guidelines).
- Experience: Previous experience in pharmaceutical quality systems or supply chain compliance is required. Experience working in dynamic, transformational environments is highly valued.
- Skills: The ideal candidate will possess strong documentation, organizational, and communication skills, along with the ability to coordinate external service providers and internal stakeholders. A collaborative, team-oriented, and customer-oriented approach is essential.
- Personal Attributes: Flexibility, the ability to manage competing priorities, high autonomy, stress resistance, and an agile personality. Applicants must be open-minded, positive, energetic, and have a proven hands-on attitude.
- Language: Advanced knowledge of English is mandatory. Good knowledge of Microsoft applications and computer skills is also required.
How to Apply
This is a full-time position based in Ankleshwar. Interested and qualified candidates are encouraged to apply before the application deadline of 20th October 2026. For information on the application process, please refer to the official Zentiva career page or the original recruitment announcement.
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