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

- 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Validation Engineer (Hyderabad)
🏢 Avanteva Solutions
📍 Hyderabad