SENIOR ASSOCIATE

Department Details

Role Summary

• Ensure documentation aligns with internal SOPs, GMP guidelines, and regulatory expectations
• Input document data into the standard registers ensuring that the information is accurate and up to date.
• Support document creation, issuance, revision, tracking, and archival in line with the QMS and project timelines.
• Qualification & Commissioning Documentation support for URS, DQ, IQ, OQ, and PQ protocols and reports
• Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ.
• Support change control documentation related to qualification and commissioning processes.
• Cross Functional Coordination: To coordinate with Engineering, Validation, QA teams to gather required inputs, approvals, and updates for qualification documents.
• Provide support during internal and external audits by retrieving and organizing qualification/commissioning documenta...