Pradeep Prakash Khandagale

• Managed computerized system validation activities, ensuring compliance with GAMP 5 and 21 CFR Part 11 standards.
• Administered user management across computerized systems to uphold regulatory requirements.
• Evaluated data integrity controls, including audit trails and electronic signatures, to uphold compliance standards.
• Managed deviations, CAPA, and change control while ensuring accurate Trackwise documentation.
• Validated PLC, HMI, and SCADA equipment to ensure operational integrity.
• Maintained inventory of computerized systems, tracking validation status to ensure ongoing regulatory compliance.
• Performed detailed reviews of validation reports, identifying gaps that could affect product quality.
• Conducted factory acceptance testing to verify functionality for systems such as RC-40 and ultrafiltration.

• Executed software validation for computer-based and PLC-HMI systems, ensuring regulatory adherence.
• Prepared critical validation deliverables including URS, FDS, DQ, IQ, RA, OQ, IOQ, and VSR.
• Conducted risk assessments based on system criticality and complexity, enhancing validation planning effectiveness.
• Led initiatives to standardize computer system validations across multiple facilities for improved compliance.
• Conducted computer system validation activities in compliance with GAMP 5 and 21 CFR Part 11.
• Performed IQ, OQ, and IOQ testing to ensure system performance met compliance standards.
• Created impact assessment and validation project plans to ensure alignment with regulatory requirements.

- Validated PLC, HMI, SCADA-based equipment for pharmaceutical clients, ensuring system reliability and regulatory compliance.

- Developed validation deliverables and protocols (URS, FRS, FRA, DSCs, VP, IQ, OQ, TM, VSR, SRC) to ensure compliance with regulatory standards.

- Implemented life cycle methodology encompassing planning, design, testing, operation, retirement; assessed system criticality and complexity.

- Possessed extensive knowledge of regulatory requirements for computerized systems, including GXP, GAMP 5, EU Annex 11, USFDA 21 CFR Part 11.

- Created comprehensive 21 CFR Part 11 checklists to facilitate audits and ensure adherence to regulatory requirements.

- Conducted temperature and humidity mapping for areas like incubators and refrigerators.