Validation Manager – (VM 080) 7+ years
Location: India but willing to travel.
- 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.
- 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.
Apply for this post »