Key Responsibilities QMS System Planning and Compliance: Oversee the planning, implementation, and continuous compliance of the Quality Management System (QMS) to ensure operational effectiveness. Safety and Quality Compliance: Ensure adherence to safety, quality policies, and regulatory standards at all times, providing necessary support to all departments as required. Adherence to Regulatory Guidelines: Ensure all plant personnel comply with cGMP, regulatory guidelines, and Standard Operating Procedures (SOPs). Quality Review Meetings: Lead and conduct regular Quality Review meetings to monitor and drive the timely closure of QMS activities. Technical Document Review and Approval: Review and approve technical documents such as audits, documentation, validation, and compliance reports. Audit Management: Conduct internal, external, vendor, and contract manufacturing audits as per established schedules. Technology Transfer Management : Manage and monitor the technology transfer process for products to ensure successful new product introduction. Product Quality Documentation: Review and approve product quality documents including product quality reviews, stability data, batch records, and artwork. Ensure the correct submission of documents for regulatory approvals. Batch Record Review and Finished Product Release: Ensure batch record review and the release of finished products in compliance with quality standards. Stability Management: Oversee and manage the stability program for dosage forms in alignment with regulatory requirements. Validation and Qualification Approvals : Approve protocols, reports, and validation/qualification activities to ensure compliance. Calibration and Maintenance Compliance : Oversee the calibration and preventive maintenance program, ensuring compliance with the scheduled plans. Resource Allocation for QA and QC :Identify and ensure the optimal utilization of resources for the QA and QC functions. CAPA Process Management: Form investigation teams and monitor CAPA effectiveness for incidents such as OOS, OOT, OOE, OOC, complaints, recalls, etc. Trend Analysis: Review and assess trend analysis reports to ensure product quality and operational efficiency. CAPA Compliance: Ensure compliance with CAPA processes following regulatory audits, market complaints, APQR, and product recalls. Communication of Quality Issues: Communicate major product quality issues to management and relevant regulatory agencies. Audit Preparation and Hosting: Host and prepare for regulatory and customer audits, ensuring timely submission and compliance with audit reports. Outside Testing Laboratories : Identify, evaluate, and approve external testing laboratories as needed. Hygiene, Safety, and Environment Compliance : Ensure compliance with safety, hygiene, and environmental standards in the working areas, Vendor Qualification : Coordinate vendor qualification activities, including reviewing technical agreements and contracts. Customer Notification and Field Alert Reporting : Ensure timely notification to customers and field alert reporting for incidents impacting product quality. Personnel Qualification : Manage the qualification and training of personnel involved in manufacturing and QC operations. GMP Training: Provide technical training to personnel involved in Good Manufacturing Practices (GMP) operations.
Job Title
Head & GM Quality Assurance - OSD Manufacturing