Computer Systems Engineer

SHRIRAM INSTITUTE FOR INDUSTRIAL RESEARCH, DELHI

Position: Computer System Validation (CSV) Engineer

Qualifications: B Tech/MCA/M.Pharma/M.Sc

Job Location: Delhi Experience: Min. 2 years

Desirable:

• 2-6 years of hands-on experience in computer system validation and understanding of CSV lifecycle & regulatory expectations.
• Validation experience in pharmaceutical, life sciences with regulatory and compliance environment
• Knowledge of 21 CFR part 11, EU Annex 11 and GAMP
• Experience in facing audits such as USFDA, WHO, EU, GLP/ GMP, and other inspection bodies is preferable.

Job description: The role primarily involves:

• Identifying the vulnerabilities, performing risk assessment, and implementing the procedures for computerized system for effective mitigation controls.
• Manage and support for validation of Computer system, both new implementation and for existing including plans, protocols, and reports.
• Executing periodic validation/verification of computerized system.
• Ensuring overall compliance and maintaining the lifecycle documentation for GxP computerized systems as per good documentation practices.
• Assisting the IT-administrator in managing his/her roles and responsibilities.

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