Regulatory Compliance Quality Assurance 21 CFR part 11 for Computer system Validation
Having more than 24
+ years experience in QA
Working on Study compliance implementation and study related SOPs.
Specialties: 21 CFR part 11,
Implemented CMMI L 3 Ver 1.2, ISO 9001:2000, 9001:2008, 27001:2005.
Currently working on 21 CFR part 11 GAMP 4/5 for a product development company.
CMMI Ver 1.2, ISO 27001, 9001:2008
Work Terms
4-6 hrs working hours, payment fixed weekly/monthly, communication skype/Teams