Site QA Head

Role Overview: As the Site QA Head at Halol, you will be responsible for managing 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. You will ensure individual compliance with regulatory requirements, GxPs, and applicable department programs. Key Responsibilities: - Define operational strategy and road map for quality assurance management at the site in alignment with Sun Pharma compliance, product quality management objectives, and regulatory requirements. - Manage site Quality Assurance activities and resources effectively to ensure smooth QA operations. - Provide strong leadership and expertise to achieve all Quality Assurance goals at the site. - Identify and implement solutions to enhance existing site quality assurance systems and processes. - Coach and develop direct and indirect reports through performance feedback, reviews, and training opportunities. - Develop and manage site quality assurance revenue, capital budgets, and headcount projections. - Ensure availability of adequate resources, including manpower, to maintain compliance with GXP requirements. - Prepare the site for regulatory agency inspections/internal audits and implement corrective actions as needed. - Conduct Quality Management Reviews, monitor performance, and identify improvement areas. - Investigate market complaints, failures, and deviations, and implement corrective and preventive actions within set timelines. - Ensure compliance with regulatory requirements on product, process, and release procedures. - Collaborate effectively with all Sun Pharma sites and leverage synergies. - Review and track quality assurance metrics and drive improvements in deviation, change control, CAPA effectiveness, market complaints, etc. - Monitor vendor quality performance and ensure compliance with supply chain management/Global Material Sourcing processes. - Provide inputs to manufacturing, R&D, and PDL processes to ensure Quality by Design. - Design, implement, and ensure compliance with quality-related SOPs, Policies, Standards, and QA systems at the site. - Facilitate internal and regulatory agency audits and address audit findings comprehensively. - Monitor industry trends and identify opportunities to enhance site quality assurance management and processes. - Fulfill training requirements of quality assurance employees. - Ensure implementation and adherence to quality policies, standards, and procedures for computerized systems. - Review and approve documents as per quality procedures. - Collaborate with site and corporate functions for the implementation of new initiatives. Qualification Required: - B.Pharm / M.Pharm - 17 to 18 years of experience in Quality Assurance, specifically in OSD.,