QA Specialist
AnkleshwarFull-time5–9 yrsPosted over a month ago
Senior QA and testing role at (0707) Zentiva in Ankleshwar. Needs 5+ years.
About the role
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.
What you'll do
- Responsible for the quality lifecycle management of an assigned subcontracted product portfolio and independent Quality Assurance oversight of assigned products and…
- 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
What you need
- GMP
- Root cause analysis
- Safety management
- Internal audit
- ISO 9001
- Pharmacovigilance
Good to have
- Chemistry
- Biology