
PRO

Pune, India
Computer System Validation CSV Expert | Pharma QA & Compliance
Local Time - 07:28 AM
About Me
I am a Computer System Validation CSV Specialist with 20+ years of experience in Pharma, Biotech, and Life Sciences supporting global clients across India, US, UK, EU, Middle East.
I provide end to end validation and compliance services covering GAMP 5, 21 CFR Part 11, Annex 11, Data Integrity ALCOA+, and global regulatory guidelines.
What I Do:
CSV documentation URS, FRS, RA, VP, IQ/OQ/PQ, TM
SaaS, Cloud & IT System Validation
LIMS, ERP, MES, eQMS Validation
Lab Equipment Qualification
SOP writing & process documentation
Data Integrity assessments
Audit preparation USFDA, MHRA, WHO
Gap assessment, remediation & CAPA
Revalidation & periodic reviews
Why Work With Me:
✔ 20+ years pharma QA/CSV experience
✔ Strong domain knowledge in cGMP processes
✔ On time delivery, high quality documentation
✔ Experience supporting global clients remote/project based
I help organizations achieve compliance, audit readiness, and efficient validation of their computerized systems.
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$20/hr
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