Role & responsibilities
-Maintain logbooks for numbering and tracking of URS, Process Validation, Hold Time Studies, and Qualification documents.
-Execute validation activities including Process Validation, Cleaning Validation, HVAC Validation, Temperature Mapping (areas and equipment),Equipment/Instrument/System Qualification, and Hold Time Studies as per approved schedules and protocols.
-Ensure strict compliance with ALCOA+ principles and Data Integrity/Data Reliability policies during documentation and validation activities.
-Prepare and executed Computer System Validation (CSV) protocols and reports in accordance with approved protocols.
- Prepare protocols and reports for Cleaning Validation studies and performed all associated validation activities.
-Prepare and maintained the Validation Master Plan (VMP) and Site Master Plan (SMP), ensuring accurate documentation and record management. -Prepare, reviewed, and maintained documentation to support internal, external, regulatory, and FDA audits, ensuring compliance with applicable GMP requirements.
Preferred candidate profile
B.Pharma/M.Pharma candidates with relevant experience in the OSD formulation industry may share their profiles at
[email protected].
📌 Senior Officer (Tarapur)
🏢 V S International
📍 Tarapur