Title:  Site QC Head

JOB DESCRIPTION   

POSITION SUMMARY

Accountable for assuring the supply of high quality, GMP compliant drug products, 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.

Key responsibilities:

1. Assess and ensure compliance to QC regulatory requirements and track quality metrics and drive them down.
2. 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.
3. Ensure analytical methods are validated /transferred at site laboratory as per cGMP requirement and regulatory commitment.
4. Monitor and review investigations and QMS with adequate CAPA to minimize errors.
5. Design, implement and reviews with QC section heads for compliance related to SOPs, policies, standards and quality systems.
6. Design and execute continuous improvement initiatives in the site to enhance compliance, drive efficiencies and cost effectiveness.
7. Facilitate harmonization and consistent implementation of quality systems and procedures at site, in alignment with regional\global quality policies\standards.
8. 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.
9. 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.
10. Provide strong leadership and expertise to ensure achievement of all Quality Control accountabilities at site.
11. 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.
12. Ensure that performance issues are managed in a consistent and timely manner.
13. Develop site quality control revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.
14. Responsible for ensuring compliance to regulatory requirements on product, process and release procedures.
15. Responsible for ensuring smooth collaboration with all Sun Pharma sites and leveraging synergies.

MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS

Minimumum M.Sc

Experience not less than 20 Yrs

Should be in QC lead position for at least last 5 years

Should have faced 10-15 regulatory inspections such as US FDA / MHRA/ Health Canada