Key Responsibilities & Requirements:
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
Robust 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
Positive understanding of GAMP 5 with hands-on experience in Computer Systems Validation (CSV) using V-Model and CSV of Cloud computing in pharmaceutical settings
Proven experience leading CSV operations for enterprise applications and standalone instruments/equipment.

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📌 Validation Engineer Hyderabad
🏢 Avanteva Solutions
📍 Hyderabad