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

Job Description

• 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.