Expertise in CSV (Computer System Validation) in pharmaceutical domain
Expertise in computer system validation and software validation in pharmaceutical / Life Science domain and develop document & validation plan as per SDLC and experience details are below:-
1. Laboratory & Quality control system software validation (Empower/TIAMO/Chromeleon/LabX/Total V Control/Spectrum ES/UV Win labs/ICDAS/Stability Desktop).
2. Responsible for writing, executing & reporting of all validation activities including but not limited to (VP/ IRA/ FDS / FRA / IQ / OQ / PQ / TM / VSR)
3. Auditing and compliance with all functional departments as per FDA/EU regulatory.
4. PLC and SCADA based automated system software validation.
5. Environmental Monitoring software, Electronic Calibration Planner software.
6. Manufacturing equipment validation (Autoclave/Tunnel/Manufacturing vessel/Coating Machine/Tablet Compression/Metal detector).
7. Maintaining compliance of electronic records & validation document in all functional departments as per 21 CFR part 11/GAMP5 and GxP environment.
8. Awareness and training to functional department.
9. Support to functional team and contractor to finalize the document, vendor audits.
10. IT infrastructure qualification
11. Exposure of audit such as USFDA/MHRA/TGA.
12. Backup and restoration activity and document development.
13. Good presentation skill and communication skill
14. CAPA / Deviation / Change Control
15. Data integrity / Gap assessment of computerized system.
17. team leadership and planning of project activity.
Work Terms
Available as needed