Personal Information
Organization / Workplace
Gurgaon, India India
Occupation
Head - CSV
Industry
Technology / Software / Internet
Website
http://www.rb.com
About
• Experienced professional in Pharmaceutical and healthcare compliance domain with wide experience in GXP, 21 CFR part 11, GAMP 5 and other compliance requirements and adherence.
• Specialist in Life Sciences IT Compliance/CSV with extensive experience in FDA (GxP, 21 CFR Part 11), and other regulations.
• Over 10 years of experience in providing tactical direction and guidance for project teams implementing Computer Systems for new or existing GxP systems including the development and analysis of system requirements.
• Extensive experience in Global IT Quality systems creation, rollout and management including Global IT Policy, SOPs, Procedures.
• Experienced Program Manager with extens...
Tags
cloud computing in pharma
it compliance of cloud
pharmaceutical
quality agreements
iaas qualification
saas qualification
csv
See more
Presentations
(1)Personal Information
Organization / Workplace
Gurgaon, India India
Occupation
Head - CSV
Industry
Technology / Software / Internet
Website
http://www.rb.com
About
• Experienced professional in Pharmaceutical and healthcare compliance domain with wide experience in GXP, 21 CFR part 11, GAMP 5 and other compliance requirements and adherence.
• Specialist in Life Sciences IT Compliance/CSV with extensive experience in FDA (GxP, 21 CFR Part 11), and other regulations.
• Over 10 years of experience in providing tactical direction and guidance for project teams implementing Computer Systems for new or existing GxP systems including the development and analysis of system requirements.
• Extensive experience in Global IT Quality systems creation, rollout and management including Global IT Policy, SOPs, Procedures.
• Experienced Program Manager with extens...
Tags
cloud computing in pharma
it compliance of cloud
pharmaceutical
quality agreements
iaas qualification
saas qualification
csv
See more