Job Description

Job Description Educational Qualification - M.Sc or M. Pharm Experience - 18 - 20 years Job Responsibilities - 1. Ensure compliance for preparation and release of Specification, standard test procedure for raw materials, in-process and finished products. 2. Implementation and Compliance of Pharmacopeia change/updation of specification and STP of Raw materials and finished products. 3. Review and Approval of change control for revision of Specification, STP as per laboratory CAPA/incidents and in response to regulatory query. 4. Simplification of spec and STP preparation processes. 5. To coordinate with all sites, RD and RA for requirements of documentation. 6. Ensure to follow the cGMP and good documentation procedures all over the work area. 7. Evaluation of existing documents to reduce the work load of documents in the system by proposing simplification of spec and STP preparation processes. 8. Work planning and Execution for team members as per priority and as per requirement. 9. Preparation, review, approval and control of Standard Operating Procedures (SOPs) of GPL. 10. To update the group for any new requirements of General Chapters, Monographs and regulatory guideline related to central cell. Ensure to be self-disciplined and to maintain good hygiene. 11.To ensure all time readiness in the department for internal or regulatory inspections. 12. Ensure to fulfill additional requirements which are instructed by the superiors and as per the organization needs.