Validation Manager (VM 080) 7+ years

Location: India but willing to travel.

Job Description:

  • 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.

Profile:

  • Proven 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.

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