Create, review, and manage SDLC and compliance documentation for GxP and non-GxP projects, ensuring documentation quality, consistency, and regulatory compliance.
Key Responsibilities:
- Author, review, update, and maintain SDLC and validation documentation.
- Support Computer System Validation (CSV) and compliance documentation activities.
- • Create and maintain documents such as Compliance Plans, SOPs, Work Instructions, Test Protocols, Traceability Matrices, Release Notes, and User Guides.
- Support change management, release management, audits, and periodic reviews.
- Maintain project artifacts and documentation within Asset Management tools.
- Assist with risk assessments, incident documentation, testing documentation, and requirements traceability.
Skills Required:
- Technical writing and documentation skills
- SDLC and CSV knowledge
- GxP and compliance understanding
- Solid communication and proofreading skills
- Microsoft Office and documentation tools expertise
Experience- 4-9 Years
Location-PAN India
Notice Period- Maximum 60 Days
Note: Please do not apply if your skills do not match.