Site QA Head

As the Site QA Head at Halol, your primary responsibility will be to manage the overall quality assurance oversight and site activities related to quality systems. This includes documentation review, SOP updates, in-process quality assurance, sampling and batch release, preventive maintenance, calibration, qualification, validation, internal audits, compliance, quality oversight of electronic systems, budget management, continuous improvement of quality systems, RA support, monitoring of pest control, and retention sample management as per Good Manufacturing Practices requirements. Your key responsibilities will include: - Defining operational strategy and roadmap for quality assurance management at the site in alignment with Sun Pharma compliance, product quality management objectives, and regulatory requirements. - Managing site Quality Assurance activities and resources effectively to ensure smooth operations. - Providing strong leadership and expertise to achieve all Quality Assurance objectives at the site. - Identifying and implementing solutions to enhance existing quality assurance systems and processes. - Coaching and developing direct and indirect reports through performance feedback, annual reviews, and training opportunities. - Managing site quality assurance revenue, capital budgets, and headcount projections. - Ensuring availability of adequate resources, including manpower, to maintain compliance with GXP requirements. - Ensuring readiness for regulatory agency inspections and internal audits, and implementing corrective actions as needed. - Conducting Quality Management Reviews, monitoring performance, and identifying areas for improvement. - Investigating market complaints, failures, deviations, and implementing corrective and preventive actions. - Ensuring compliance with regulatory requirements on product, process, and release procedures. - Collaborating smoothly with all Sun Pharma sites and leveraging synergies. - Reviewing and tracking quality assurance metrics and driving improvement in deviation, change control, OOS/OOT, CAPA effectiveness, and market complaints. - Following processes for vendor selection, qualification, and monitoring vendor quality performance. - Providing inputs to manufacturing, R&D, and PDL work processes to ensure Quality by Design. - Designing, implementing, and ensuring compliance with quality-related SOPs, policies, standards, and QA systems. - Facilitating internal and regulatory agency audits and addressing findings comprehensively. - Monitoring industry trends to identify opportunities for improving site quality assurance management. - Fulfilling all training requirements of quality assurance employees. - Ensuring implementation and adherence to quality policies, standards, and procedures for computerized systems. - Reviewing and approving documents according to quality procedures. - Collaborating with site and corporate functions for the implementation of new initiatives. The minimum education and experience requirements for this position are a B.Pharm / M.Pharm degree with 17 to 18 years of experience in Quality Assurance, specifically in OSD.,