Associate Director Quality Professional

Role & responsibilities

• Continuously improve the TAPI cGxP Computerized Systems policies, standards, procedures, tools and training.
• Manage site inspection readiness and support with regards to globally managed Computerized Systems.
• Guide TAPI Sites IT and IT QA on inspections trends, observations, authorities expectations and best practices that can mitigate gaps.
• Deliver training programs to TAPI Computerized systems owners.
• Support sites with any IT related project(s) as required.
• Support sites in with computer systems validation, infrastructure qualification and systems life cycle management, together with any remediation needed.
• Conduct GxP computerized systems gap assessments/evaluations with applicable regulations
• Provide QA IT review and approval on all globally managed Computerized System deliverables.
• For some globally managed Computerized System, provide QA IT review and approval on the System deliverables, and for others, represent site users, as System Business Owner.

Qualification & experience

• BE / B.Tech in Information Technology
• 10 to 15 years of experience

Email:trupti.kauthankar@teva.co.in