Key Responsibilities & Accountability – Handled Individually
- Responsible for review and execution of all validation & qualification activities at site pertaining to equipment's, utilities and area qualification.
- Responsible for preparation and review of Standard Operating Procedure, protocols & reports, Validation master plan, Site master file, Quality manuals etc.
- Responsible for execution of process validation, hold time studies, cleaning validation and other miscellaneous validation activities as and when required.
- Responsible for execution of thermal mapping and Transport validation studies.
- Responsible for preparing and effective implementation of SOP for handling of outside service providing agencies.
- Responsible for effective implementation of computer system validation, ALCOA+++ principle, Learning management system, Quality risk management, Quality management system.
- Lead and supervise cross-functional teams in Quality Assurance, Microbiology and Quality control.
- Assign tasks, monitor performance to ensure departmental goals are met.
Secondary Responsibilities
- Responsible for implementation and ensuring effectiveness of Quality Management System at site pertaining to CAPA, Change control, Quality events, QRM etc.
- Responsible for providing resources and guidance to executives, officers to carry out their job responsibilities.
- Coordination with production for the preparation, review and issuance of Batch manufacturing record, Batch packing record.
- Responsible for line clearance activities as per the approved batch manufacturing record.
- Responsible for review and identification of gaps in procedure and practices against cGMP requirements.
Soft Skills Required:
- Cross-functional coordination
- Training Planning & Scheduling
