Head QA QC - API

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 ICHQ7/EUDRALUX IV compliance, product quality management objectives and regulatory requirements.
• MUST Have hands on experience of handling of regulatory audits like USFDA/EDQM/PMDA/ANVISA
• 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 cross functional teams 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. In-depth knowledge of QC.