Job Purpose: To oversee the end-to-end procurement, lifecycle management, and validation of GxP-regulated equipment and software. This role ensures total compliance with cGMP, 21 CFR Part 11, and QMS standards while maintaining a safe, environmentally compliant operational environment.
Responsibilities: - Supporting the team for procuring equipment and preparing the related documents such as User Request Specification (URS), CAPEX approval, technical comparison sheet and procurement of equipment/software.
- Equipment life cycle management along with corresponding teams.
- QMS (Ample Logic) activities related to equipment/software/system /CSV (new and legacy equipment) before & after installation and maintenance.
- Supporting the team for preparing and updating SOPs related to equipment/software spare parts and column system per cGMP.
- Guiding the team for procuring (requesting & approval) and maintaining columns with the r...