Projects Documentation at MNC Pharma Company at Digwal

Job Description:

It will be on third party payroll of Talisman HR Solutions Pvt Ltd

2. Preparation of URS, DQ, IQ, OQ, and PQ protocols and reports for process equipment, utility systems, HVAC systems, and water systems in compliance with GMP requirements.
3. Preparation, review, and revision of SOPs for the Projects Department as per QA requirements and regulatory compliance.
4. Preparation and review of Project BOQ (Bill of Quantities) and technical specifications.
5. Checking and verification of Instrumentation BOQ, P&ID drawings, GA drawings, and layout drawings for projects.
6. Preparation and review of equipment and instrumentation data sheets and engineering drawings.
7. Vendor document review, technical bid evaluation, and coordination with vendors for technical clarifications.
8. Inspection of mechanical equipment, instruments, and accessories as per approved specifications and purchase orders.
9. Preparation and execution documentation (URS, DQ, IQ, OQ, PQ) for PLC, SCADA, and automation systems.
10. Preparation of Master Calibration Schedule and allocation of tag numbers for all field instruments as per project standards.
11. Change Control documentation, deviation handling, and coordination with QA for approvals.
12. Risk assessment documentation (FAT, SAT, impact assessment, and mitigation planning).
13. Handover of completed projects to the E&M team after documentation closure and final approval.
14. Preparation of engineering equipment data sheets and drawings for procurement activities.
15. Monitoring and tracking of PR, PO, and GRN for ongoing projects and coordination with the purchase department.
16. Ensuring compliance with cGMP, regulatory guidelines, and audit requirements (internal and external audits).
17. Maintaining document control, version control, and archival of project documentation.
18. Coordination with cross-functional teams (QA, Production, Engineering, Maintenance, Vendors) for project execution.

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