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Validation Manager

Mumbai, MH
Job Code:
  • IT
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Job Details

Initiation and evaluation of validation requirements of systems.Planning and coordination of all validation activities.Coordination for draft and approval of Specifications documents.Assessment and verification of validation results and reports after execution.Assistance in development of project schedules with regard to validation deliverables.Onsite feedback during audits and other projects regarding validation issues represent the Validation department to contribute to Validation Planning on specific projects.Ensure timely resolution of all deviations and changes that occur during the execution phase.Develop validation standards, procedures, and guidelines for the utilization within the Validation department.Review and approve Validation protocols and summary reports generated by Validation staff against standard procedures and policies. Provide guidance to Validation staff writing protocols and final reports.Exploring new techniques, methods, and other industry practices for Computer Systems Validation.ProfileProven experience in computer systems validation, with knowledge and understanding of 21 CFR Part 11 and experience with any of the following computerized systems Data Management, Instrumentation, or LIMS etc.Strong management skills including the ability to communicate with the client, lead and motivate a team, and deliver within set deadlines.Strong knowledge of cGMP's and regulatory compliance issues.Experience with writing and executing validation plans, generating and executing SOPs and protocols, conducting testing, and preparing final summaries.Prior consulting experience.
Degree: MCA/ PGDCA

Additional Degree: BE/ B.Tech (Engineering)

Experience: 7-12


Application Programming | Database Administration (DBA) | Project Leader/ Project Manager | Software Engineer
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