Ensure all IT operations/activities from business requirements to implementation.

Leading all GxP computerised system compliance and validation, IT activities, SAP Projects, Manufacturing automation projects, Laboratory system and serialization

Presently Leading IT Compliance team in Wockhardt ltd India, Handle complete operation of CSV, Compliance & IT Quality Activities. Face Regulatory Audits at sites for IT systems.•Ensure that all Computerized Systems operating in GxP Impacting Business Processes are Developed/Implemented in Compliance with Organizational Procedures, regulatory requirements and Maintained in the state of Validation.•Perform Vendor Audit of all enterprise level system as per IT Vendor assessment SOP & Regulatory guidelines•Prepare Validation Strategy for cGxP computerized Systems to ensure consistency with quality & regulatory standards•Understand Business requirements and configure the system in such a way that it meets business & regulatory(21 CFR) requirements .•Prepare CSV policies,& IT related Regulatory Procedures.

Handle Multiple projects for GSK as a client.Prepare request document to determine re-validation or validation review requirements of different Application.

Developing Complete & Comprehensive Validation Strategy, Quality/Project Validation Plan & Fulfilled technical service and validation support functions to Manufacturing sites Re-validation of the Application systems & IT Infrastructure after upgrades to comply with regulatory guidelines.Completing 21 CFR Part 11 compliance assessments of laboratory and manufacturing systems, including remediation and validation of deficient systems.

Ensure compliance and provide Computer System Validation services to the European IT teams for client Eli-Lilly & Company •Involved in analysis and collection of requirements for validation activity of computer system application by mutual discussions with the system custodian, system owner & BI. •Support, Review and write Software Validation Life cycle documents (Validation plan, Requirement, Vendor assessment, GxP assessment, Validation report, System acceptance).•Review and mutual discussion with System custodian & BI of Configuration and Change Requests of software and systems and determine re-validation or validation review requirements.