Sanjay Padhiyar

Ensure Computer system compliance and projects are executed with adherence to regulatory requirements

Author key validation deliverables, Provide GxP related expertise and partner with key business stakeholders in defining CSV strategy

Review validation impact analysis ans risk assessments, both high level and functional to ensure requirement coverage

Author pCMA (Project control maturity assessment) and coordinate with project stakeholders to ensure that applicable controls are assessed and addressed.

Contribute to project related audits, assessment or inspection during or after the project life cycle

To Perform, Review and assist for global projects Computerized System Validation activity within Organization.

Provide the Audit support as and when required for the Internal as well as Regulatory Agency Audits

Lead of validation of IT systems like Electronic Document Management System (EDMS), Electronics Quality management system (EQMS) and ERP system (SAP); also involved in the upgradation and re-validation of SCADA/PLC and HMI based equipment’s

Involved and initiating of CAPA (Corrective Action & Preventive Action) reports and change to ensure compliance with established procedure.

Authored, reviewed and approved CSV deliverables impact assessment, GxP assessment, Risk assessment,21CFR Part 11 Assessment, URS, FRS, CS, SDS, DQ, IQ, OQ, RTM, VSR.

Take trial and testing of New equipments, Software. (FAT, SAT).

Preparation of vendors list, Vendors schedule, Vendor assessment.

Preparation of monthly periodic review check sheet for computerized and automated system

To Perform Computerized System Validation (PLC, SCADA, Vision System, etc.) at the time of Qualification / Requalification / Upgradation on client site,

Communicated the daily operations of the validation team to the management and assured that the master plans, protocols and reports are generated, reviewed and approved within predetermined timelines.

preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment