Darsh Patel

Validation Specialist @PCI Pharma Services

Philadelphia, PA, US

Represents validation for the qualification and validation of packaging equipment and processes to ensure compliance with regulatory standards and customer expectations. • Execute packaging equipment qualifications, product packaging validations, and cleaning validation activities.• Perform computer system validation activities in accordance with 21 CFR Part 11 and data integrity requirements.• Support Environmental monitoring, facilities/ utilities qualification, and temperature mapping• Participate in internal, customer, and regulatory audits.• Conduct periodic evaluations and gap assessments for requalification needs.• Provide peer reviews for validation protocols and reports.• Ensure timely completion of CAPAs and training assignments.• Contribute to continuous improvement initiatives within the Validation team.

Parsippany Hills High School

High School Diploma