We are hiring Computer System Validation Specialist/Analyst role for Delhi/Hyderabad/Bangalore Location.
Role: Computer System Validation Specialist/Analyst
Skills: CSV, CSA, SDLC, Risk Management, GAMP,
Experience: 6+ years
Location: Delhi/Hyderabad/Bangalore
Minimum Qualification:
15 years of full time education BE/B.TECH/BCA/MCA/MSC
Job Description:
The Computer System Validation (CSV) Specialist is responsible for ensuring that computerized systems used in regulated settings are validated and maintained in a compliant state throughout their lifecycle. This role ensures systems meet intended use, regulatory requirements, and internal quality standards through risk‑based validation, documentation, and change management.
Must Have Skills:
• In-depth understanding of Computer System Validation (CSV) and Computer Software Assurance(CSA).
• Understanding SDLC and its various phases/ stages.
• Understanding and Expertise in Risk Management (ICH Q9 and ICH Q8).
• Understanding of GAMP categories.
• Understanding of Industry Standards like ISO 13485
• Understanding on QMS and regulations like 21 CFR Part 820
• Understand GSM (SDLC) methodology and different procedures to implement it.
• Understanding and implementation expertise of CSV deliverables.
• Provide consultations to project teams on how to implement validation as appropriate for the selected S/W Validation approach.
• Recommend project teams which validation approach might be more suitable for them.
• Understand SOP and Work Instructions and guide project teams on how to create deliverables.
• Understand Regulatory compliance like PI/ PHI, ERES (21 CFR Part 11) to the extent to provide consultation when required
• Expertise on change management process and Provide consultation to implement Software changes.
• Review and Approve Validation deliverables and System changes.
Key Responsibilities
Computer System Validation
• Plan, execute, and maintain validation activities for GxP‑rele