QC Inspection Supervisor

QC Head (API)

Business Unit

Global Quality & Compliance

At Sun Pharma, we commit to helping you 'Create your own sunshine'— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Accountable for assuring the supply of high-quality, ICH Q7‑compliant APIs / bulk drug substances, define operational strategy for quality control system at site, facilitate in finalizing quality control goals, objectives and strategy in line with Sun Pharma compliance, product quality management objectives and regulatory requirements, conduct effective review of the team and portfolio and provide direction and guidance to the team and develop team competence with the objective of ensuring Quality of products manufactured and released with adherence to GMP norms and timelines.

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.

Assess and ensure compliance to QC regulatory requirements and track quality metrics and drive them down for API Panoli site .

Effectively manage the site Quality Control activities and resources necessary to smoothly run the QC operation including

release of raw materials, intermediates, in‑process samples, APIs, and monitoring API stability as per regulatory commitments.

Ensure analytical methods (for intermediates and APIs) are validated/transferred as per ICH Q2 and API regulatory requirements.

Monitor and review investigations and QMS with adequate CAPA to minimize errors.

Design, implement and reviews with QC section heads for compliance related to SOPs, policies, standards and quality systems.

Facilitate harmonization and consistent implementation of quality systems and procedures at site, in alignment with regionalglobal quality policiesstandards.

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.

Facilitate arrangement of all the resources required to QC laboratory to achieve desired productivity, SLA defined as per KPI by continual improving the process excellence.

Provide strong leadership and expertise to ensure achievement of all Quality Control accountabilities at site.

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.

Ensure oversight of impurity profiling (including genotoxic impurities), residual solvent testing (ICH Q3C), particle size distribution, and API-specific quality attributes.

Develop site quality control revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.

Responsible for ensuring compliance to regulatory requirements on product, process and release procedures.

Travel Estimate

Pharm / M.Pharm

Experience

We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).