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SHRIRAM INSTITUTE FOR INDUSTRIAL RESEARCH, DELHI
Position: CSV personnel
Department: ASD/Bio./CIF-IT
Qualifications: B Tech/MCA
Job Location: Delhi Experience: Min. 3 years
Desirable:
3-7 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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