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/PDMA/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 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.

Educational Qualification -

- M.Sc. / M.Pharm / B.Pharm / equivalent qualification in Chemistry, Pharmacy, Pharmaceutical Sciences or a relevant technical discipline.
- Additional qualification or training in Quality Assurance, Regulatory Affairs, GMP or related areas will be an advantage.

Location - Bharuch, Gujarat

Experience -

- 15–20+ years of relevant experience in QA/QC/Regulatory Affairs within the API / pharmaceutical / regulated manufacturing industry.
- Robust experience in GMP, ICH Q7 and Quality Management Systems.
- Proven experience in leading regulatory, customer and third-party audits/inspections.
- Experience in managing QA and QC teams at manufacturing sites.
- Strong experience in deviations, OOS/OOT, CAPA, change control, validation, data integrity and Quality Risk Management.
- Experience with DMF/CEP and other regulatory submissions.
- Experience in dealing with international customers and regulatory authorities.
- Experience of managing Quality across multiple manufacturing sites will be strongly preferred.
- Experience in obtaining/maintaining regulatory licences and preparing manufacturing sites for regulated markets will be an advantage.

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