Site QA Head

Position: Site QA Head

Reports to: Site Quality Head

Department: Quality

Location: Halol

Position Summary

Manage overall quality assurance oversight and site activities wrt to quality systems: documentation review and SOP update, in-process quality assurance, sampling and batch release, preventive maintenance/calibration/qualification/validation, internal audit, compliance, quality oversight of electronic systems, budget, and continuous improvement of quality systems, RA support, monitoring of pest control, retention sample management as per Good Manufacturing Practices requirements.

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.

Key Responsibilities

• Responsible for defining operational strategy and road map for quality assurance management at site. Define site quality assurance goals and strategy in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.
• Effectively manage the site Quality Assurance activities and resources necessary to smoothly run the QA operation at site.
• Provide strong leadership and expertise to ensure achievement of all Quality Assurance accountabilities at site.
• Identify and implement solution for improving existing site quality assurance systems and processes.
• Coach and develop both direct and, as appropriate, indirect reports through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities.
• Ensure that performance issues are managed in a consistent and timely manner.
• Develop site quality assurance revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.
• Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements.
• Assure all time readiness of site for regulatory agency inspections\internal audits and appropriate implementation of corrective actions regarding observations made by the agencies\internal audit teams.
• Responsible for executing Quality Management Reviews at site, monitor individual Performance and set improvement areas.
• Responsible for ensuring market complaints, failures, deviations are investigated and corrective and preventive actions are implemented as per set timeline.
• Responsible for ensuring compliance to regulatory requirements on product, process and release procedures. Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment.
• Responsible for ensuring smooth collaboration with all Sun Pharma sites and leveraging synergies.
• Review & tracking of quality assurance metrics e.g. deviation, change control, OOS/OOT, CAPA effectiveness, market complaints with site manufacturing / QC Management and driving them down.
• Ensure processes for supply chain management / Global Material Sourcing for vendor selection is followed for vendor selection, qualification and monitor vendor quality performance
• Provide inputs to manufacturing, R&D and PDL work processes to ensure Quality by Design.
• Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and QA systems at the site.
• Facilitate internal and regulatory agency audits, ensuring that findings from site audits are understood, assessed and addressed site wide in a comprehensive manner.
• Monitor industry trends/issues faced internally and identify scope for improving Site quality assurance management and processes.
• Responsible for fulfilling all training requirements of quality assurance employees.
• Ensure the quality policies, standards and procedures for computerized systems are implemented and adhered at site. Ensure all GxP computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle with adequate security and controls to ensure data security.
• Review and approve the documents as per quality procedures.
• Work in partnership with the site cross functions and corporate functions for implementation of new initiatives.