Job Description
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 & preparing the related documents like User request specification (URS), CAPEX approval, technical comparison sheet and procuring the 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 the installation and Maintenance.
- Supporting the team for preparing and updating the SOPs related to Equipment/software spare parts and column system as cGMP.
- Guiding the team for procuring (requesting & Approval) and maintaining columns with the respecting...