MISSION STATEMENT
The ESO Quality QA Specialist is responsible for the quality lifecycle management of an assigned subcontracted product portfolio and independent Quality Assurance oversight of assigned products and suppliers.
The role ensures compliance with applicable Quality Management System, GMP, GDP and regulatory requirements and supports audits, product lifecycle activities and quality decision-making.

MAIN ACCOUNTABILITIES AND DUTIES
- Operational quality management of an assigned product portfolio, including:
- Independently manage routine deviations, complaints and related CAPAs.
- Conduct Root Cause Analysis and follow up agreed corrective and preventive actions.
- Review and assess change controls and their Quality impact.
- Review GMP manufacturing documentation, analytical data, CoAs/CoCs and relevant batch documentation.
- Support batch release decisions through review of Quality documentation.
- Collect and independently review PQRs and stability data.
- Conduct routine Quality Risk Assessments.
- Review qualification and validation protocols and reports.




- Assess compliance of assigned third parties, suppliers and products.
- Review supplier Quality documentation and support supplier Quality management activities.
- Prepare and maintain Quality Agreements with third parties and subcontractors.
- Identify potential Data Integrity risks and escalate where appropriate.
- Provide QA support for product launches, transfers and lifecycle activities.
- Apply GMP, GDP, ICH and other applicable regulatory requirements independently.
- Prepare for and participate in external supplier audits, internal audits and inspections.
- Review audit reports and follow up agreed actions.
- Monitor Quality KPIs, analyse relevant data and support Quality decisions.
- Maintain product and Quality databases and use applicable QMS systems independently.
- Communicate effectively across functions and with external partners.
- Manage routine Quality discussions and negotiatio

📌 QA Specialist (Ankleshwar)
🏢 Zentiva Group
📍 Ankleshwar