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 inspectionsinternal audits and appropriate implementation of corrective actions regarding observations made by the agenciesinternal 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 secure 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.

📌 Head QA QC - API (Bharuch)
🏢 BEC Chemicals
📍 Bharuch