Designation : General Manager – Quality Assurance
Role : General Manager
Functional Area : Quality Assurance / Regulatory Affairs
Education : B.Pharm / M.Pharm / MSc
Industry Type : Pharma, Biotechnology
Experience : 20 - 25 Years
Compensation : Negotiable
Location : Dholka
- To establish, implement and improve quality system as per Q7A, EU GMP and other international guidelines.
- To lead and provide guidance and trouble shooting of technical activities related to Quality control and quality assurance.
- As a management representative organize, implement and participate in internal audits. Responsible for review of internal audit non- conformances and its implementation status.
- To approve all standard operating procedures and test and master batch manufacturing record.
- To approve protocol and report of process validation and analytical method validation.
- Responsible for product quality review.
- Responsible for preparation and submission of Drug Master Files and dossier for certificate of suitability for US, Europe and other countries.
- To approve and release the API for sale, if required.
- Responsible for responding to the FDA and liaison with US and European regulatory authorities.