Associate - CSV

CSV Activities

• Assist in preparation, review, and execution of CSV deliverables (URS, FS, DS, Risk Assessments, IQ/OQ/PQ, Validation Summary Reports).
• Support data integrity assessments and system impact/GxP assessments in line with GAMP 5 (2nd Edition).
• Maintain validation traceability using RTM and structured templates.
• Participate in audit readiness activities and document compilation.

Learning Content Preparation

• Develop interactive training modules on CSV, GxP, Data Integrity, Annex 11, 21 CFR Part 11, etc.
• Design and build SCORM-compliant e-learning content using authoring tools (Articulate Storyline, Captivate, or equivalent).
• Create animated/interactive content (flowcharts, quizzes, simulations) for Pharma domains:
• Quality Assurance & Control
• Manufacturing Processes
• Computerized Systems & Data Integrity
• Regulatory Guidelines & GxP Training
• Prepare training decks, SOP summaries, quick reference guides, and knowledge aids.
• Collaborate with SMEs (QA, IT, L&D) to translate technical content into learner-friendly modules.
• Support LMS content upload, testing, and tracking of learning completion.

Job Types: Full-time, Internship, Contractual / Temporary
Contract length: 6 months

Pay: ₹176,211.90 - ₹300,000.00 per year

Benefits:

• Work from home

Work Location: In person