In-depth knowledge of regulatory guidelines for both CSV and PLC Validation (both mandatory):

21CFR Part 11 ERES

GAMP5

Part 820

Part 210 & 211

EU Annex 11

ICHQ9

Experience in developing and implementing CSV framework at organizational level meeting regulatory requirements

Expertise in managing Gap Analysis & Risk Assessment

Strong exposure in Information Technology and IT Quality of Computer Systems/Software Validations

Experience in assessment and remediation of computerized systems for Electronic Record & Electronic Signature (ER/ES) compliance, including data security, traceability, and integrity

Good understanding of GAMP 5 with hands-on experience in Computer Systems Validation (CSV) using V-Model and CSV of Cloud computing in pharmaceutical environments

Proven experience leading CSV operations for enterprise applications and standalone instruments/equipment.