CSV Consultant

· Develop and execute Validation Strategy and Plans for applications, infrastructure, and tools.

· Author and review validation deliverables: Validation Plan (VP), Risk Assessment, IQ/OQ/PQ protocols, Validation Summary Reports.

· Ensure compliance with GxP, GAMP 5, FDA 21 CFR Part 11, Part 820, EU GMP Annex 11, and other regulatory guidelines.

· Perform gap analysis, feasibility studies, and recommend best practices for validation.

· Collaborate with Quality Assurance, IT, and Business teams to ensure adherence to SOPs and validation lifecycle.

· Support audit readiness and participate in internal/external audits.

· Guide teams on risk-based validation approaches and maintain traceability throughout SDLC.

· Hands-on experience with Validation tools (e.g., ValGenesis, Knead) and document management systems.

· Drive continuous improvement initiatives in validation processes and compliance frameworks.

Required Skills

· 2 - 10 Years of experience in CSV

· Strong knowledge of Pharma GxP environment, Computer System Validation, and Quality Management Systems.

· Familiarity with CAPA, deviations, and change control processes.

· Proficiency in Agile/Waterfall methodologies and SDLC deliverables.

· Excellent communication and documentation skills.

1. Project Duration: 1 Year

2. Type of Work: Bangalore

3. Location: Bangalore

4. profiles based out of Bangalore/Chennai preferable