Position: Head - Corporate Quality Assurance (Mumbai) Reporting to Vice President - Global Quality & Regulatory Affairs - 18+ years of experience in Quality & Regulatory department from Pharmaceutical / Nutraceutical industry - Sound knowledge of Quality Management Systems - Sound knowledge of statutory and regulatory requirements - Pharma concepts - Process knowledge to facilitate qualifications as well as risk assessments Key Deliverables : - Defining & Implementing the QMS - Defining QA SOPs such as Change Control, OOS, Deviation, etc - Effectiveness of QMS - Conduct routine internal audits of plants - Work with the plants to define CAPA - Monitor effectiveness of CAPA emanating form audits, complaints & internal review - Ensure preparedness for external audits (customer & regulatory), participate in critical audits - Vendor Qualification (materials, services, logistics) - New + existing plant, process and equipment qualification - Liaise with projects and service provider for new facility qualification in line with VMP - Define the VMP & monitor its implementation - Train projects, operations, plant QA on validation and qualification requirements - Review validation reports, ensure they are adequate and complete - Approval of new facility layouts, RDS, Weight list, etc - Risk assessment and mitigation - Define risk assessment policy in line with ICH guidelines - Monitor for risk mitigation compliance

Mumbai

Head - Corporate Quality Assurance - Pharma 

Head - Corporate Quality Assurance - Pharma  ,Job Description for Head - Corporate Quality Assurance - Pharma  in Gateway Solutions in  Mumbai for (18-25) years of experience. Apply Now!

Job Description for Head - Corporate Quality Assurance - Pharma  in Gateway Solutions in  Mumbai for (18-25) years of experience. Apply Now!