Abhijeet Shinde

Experienced in leading and executing Computer System Validation (CSV) activities, with a strong focus on ensuring compliance.

Key responsibilities and achievements include:

• implementation of the Learning Management System (LMS) across major Piramal's sites, ensuring seamless training management and compliance with GxP regulations.
• Leading automation and digitalization initiatives, particularly the successful implementation of the SMARTVal system as a validation tool, enhancing efficiency in the validation process.
• Conducting risk assessments, periodic reviews, and audit trail reviews of GxP systems, ensuring ongoing compliance and identifying areas for process improvements.

• Supported Computer System Validation (CSV) activities, ensuring compliance with regulatory standards.
• Ensured data integrity through validation processes and adherence to industry regulations.
• Collaborated with compliance teams to support and align validation activities.
• Contributed to enhancing GxP systems to meet regulatory and business needs.

• Visited Piramal's manufacturing sites to understand business processes.
• Attended training workshops on data integrity and quality compliance.
• Supported CSV team in validation and compliance activities.

• Completed one month in-plant training in Emcure pharmaceuticals Limited.
• Worked in OSD manufacturing site