Job Summary
Senior Executive QA – Biologics is responsible for overseeing quality assurance activities related to biologics, manufacturing, ensuring compliance with cGMP, regulatory guidelines (FDA, EMA, ICH), and company quality standards.
Key Responsibilities
Provide QA oversight for biologics manufacturing operations including upstream,
downstream, and fill-finish processes.
To handle Training management, Document management and QMS.
To handle development quality assurance activities.
Ensure compliance with cGMP, GLP, GDP, and regulatory guidelines.
Review and approve batch manufacturing records (BMRs), SOPs, protocols, and reports.
Support technology