Pankaj Dubey

• Lead validation strategies and review CSV deliverables for IT projects, ensuring compliance with regulatory standards.
• QeC SPOC for all SAP enhancements and SAP-ATTP Projects.
• Collaborate with global and local teams to align CSV activities with organizational objectives.
• Conduct IT supplier assessments and manage compliance with audit observations.
• Facilitate communication with Site IT compliance SPOCs and provide training on CSV, Data Integrity, and Regulatory Compliance.
• Oversee the integration and support of validation processes within the organization.

• Managed and promoted compliance across Quality Assurance and cross-functional teams.
• Led Computer System Validation for technology transfers and new projects, ensuring adherence to GMP and regulatory standards.
• Developed, reviewed, and approved CSV deliverables, including Validation Project Plans, URS, TM, IQ, PQ, UAT, and more.
• Coordinated server qualifications, conducted investigations, and simplified processes to enhance efficiency.
• Certified cGMP technical trainer and lead internal auditor, overseeing system upgrades and maintenance.

• Monitored and reported on quality performance indicators, ensuring regulatory compliance.
• Reviewed validation/qualification protocols and handled customer complaints and deviations.
• Managed audit compliance reports, CAPA tracking, and internal and external audits.

• Oversaw QMS, quality risk assessments, and validation document reviews.
• Conducted training, managed audits, and handled change controls and incident investigations.

• Reviewed equipment qualification documents and master documents, including site master files and SOPs.
• Managed change controls, deviations, and customer complaints and conducted risk analysis.

Performed IPQA activities, sampling, and process validation, and managed document issuance and control.