Company: Sun Pharmaceutical Industries Ltd
JOB DESCRIPTION
Position: Site QC Head
Reports to: Site Quality Head
Grade: Sr.GM
POSITION SUMMARY
Accountable for assuring the supply of high quality, GMP compliant drug products, defining operational strategy for quality control system at site, facilitating the finalization of quality control goals, objectives, and strategy in line with Sun Pharma compliance, product quality management objectives, and regulatory requirements. The incumbent will assure individual compliance with all concerned regulatory requirements, GxP’s, and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.
Key responsibilities:
- Assess and ensure compliance to QC regulatory requirements and track quality metrics and drive them down.
- Effectively manage the site Quality Control activities and resources necessary to smoothly run the QC operation including release of incoming materials, drug products, and facilitating stability studies of commercial products as per cGMP requirement and regulatory commitments.
- Ensure analytical methods are validated/transferred at site laboratory as per cGMP requirement and regulatory commitment.
- Monitor and review investigations and QMS with adequate CAPA to minimize errors.
- Design, implement, and review compliance related to SOPs, policies, standards, and quality systems.
- Design and execute continuous improvement initiatives in the site to enhance compliance, drive efficiencies, and cost-effectiveness.
- Facilitate harmonization and consistent implementation of quality systems and procedures at site, in alignment with regional/global quality policies/standards.
- 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 resources required for QC laboratory to achieve desired productivity, SLA defined as per KPI by continually 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.
- 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.
- Responsible for ensuring smooth collaboration with all Sun Pharma sites and leveraging synergies.
MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS
Minimum experience not less than 22-25 years in reputed organizations.
Should be in QC lead position for at least the last 5 years.
Should have faced 10-15 regulatory inspections such as US FDA / MHRA / Health Canada.
Having experience of sterile manufacturing and non-sterile manufacturing labs.
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