Group Leader

Job Description

Purpose of the role: Responsible for stability Management Primary Responsibility: Strategic: 1. Ensure 100% compliance to usage of Quality systems. Operational: 1. Adherence of cGMP (Current Good Manufacturing Practice) and cGLP (Current Good Laboratory Practice). 2. To have control and ensure the Stability team management. 3. To ensure the stability samples are analyzed and released as per schedule. 4. To ensure none of the stability samples are being crossed the window period. 5. Review of Stability samples in quality control department. 6. Instrument/Equipment qualification Review in Quality control. 7. Preparation and maintenance of quality records and study protocols. 8. Preparation of quality system related, Instrument operation related SOPs, Specification, STPs, URS etc. 9. Coordinate with cross functional teams such as Production, QA, Warehouse, SCM etc. 10. Review of method transfer and method validation in quality control. 11. Handling of QMS elements related to quality control. 12. Maintenance and calibration of instruments in Quality control. 13. Quality Interface in audits (both internal and external) and ensure appropriate QMS document identified in a timely manner and closed out. 14. Analysis of vendor samples and reporting. 15. Follow approved STPs, SOPs, and Specifications 16. To ensure readiness for Customer and regulatory audits. 17. Providing the support to meet the management objectives of product deliveries on time in line with Quality Management system. 18. Support quality related activities in other sites of Stelis (as required)