Asst Manager / Manager Quality Assurance - Pharma

As a Quality Assurance Manager for the Pharma Vertical at Cotecna Life Sciences India Pvt Ltd. (Erstwhile Geochem Laboratories), your role will involve the following responsibilities: - Establish, implement, and maintain the Quality Management System in alignment with current GxP activities, including ISO/IEC 17025:2017 standards. - Make independent and timely decisions related to GxP quality and compliance requirements. - Host and provide support during regulatory and customer audits. - Train and mentor staff on GxP regulations, manage GxP and ISO documentation systems, and oversee the training program. - Align Quality Assurance Standard Operating Procedures (SOPs) with guidelines and best practices. - Ensure the laboratory participates in various Proficiency Testing or inter-laboratory comparisons conducted periodically. - Proactively assess quality and compliance risks to prevent recurring issues or potential risks to lab operations. - Develop an annual internal audit program, conduct internal audits, and monitor corrective actions. - Handle deviations, Out-of-Specification (OOS) investigations, customer complaints, and Corrective and Preventive Actions (CAPA) promptly. - Manage the change control system and address deviations from management systems or procedures for laboratory activities. - Provide reports to laboratory management on system performance and suggest improvements. - Ensure the effectiveness of laboratory activities and review Quality Agreements with customers. - Coordinate Management Review Meetings and escalate quality issues to management promptly. - Undertake any other tasks assigned by the Management. Qualification Required: - M.Sc in Chemistry Experience: - 10 to 15 years Work Location: - Digha (Navi Mumbai) As a Quality Assurance Manager for the Pharma Vertical at Cotecna Life Sciences India Pvt Ltd. (Erstwhile Geochem Laboratories), your role will involve the following responsibilities: - Establish, implement, and maintain the Quality Management System in alignment with current GxP activities, including ISO/IEC 17025:2017 standards. - Make independent and timely decisions related to GxP quality and compliance requirements. - Host and provide support during regulatory and customer audits. - Train and mentor staff on GxP regulations, manage GxP and ISO documentation systems, and oversee the training program. - Align Quality Assurance Standard Operating Procedures (SOPs) with guidelines and best practices. - Ensure the laboratory participates in various Proficiency Testing or inter-laboratory comparisons conducted periodically. - Proactively assess quality and compliance risks to prevent recurring issues or potential risks to lab operations. - Develop an annual internal audit program, conduct internal audits, and monitor corrective actions. - Handle deviations, Out-of-Specification (OOS) investigations, customer complaints, and Corrective and Preventive Actions (CAPA) promptly. - Manage the change control system and address deviations from management systems or procedures for laboratory activities. - Provide reports to laboratory management on system performance and suggest improvements. - Ensure the effectiveness of laboratory activities and review Quality Agreements with customers. - Coordinate Management Review Meetings and escalate quality issues to management promptly. - Undertake any other tasks assigned by the Management. Qualification Required: - M.Sc in Chemistry Experience: - 10 to 15 years Work Location: - Digha (Navi Mumbai)