Validation Engineer

• 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.

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