Join our dynamic team and shape the future of CSV with cutting-edge solutions.
Position Title: Validation Engineer
Qualifications: Any graduate/post-graduate
Experience Required: 1-5 years (Pharma)
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
- 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.
Fill the below form to apply -
https://forms.gle/KH6yK52XdZQV6FQp7
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