Job description
- Position: CSV Specialist
- Location: Pan India (Preferred: Hyderabad, Bengaluru, Mumbai)
- Department: Quality & Validation
- Role Overview: Responsible for Computerized System Validation (CSV) and project management of GxP IT applications, computerized systems, and automation systems. Ensures compliance with global regulatory standards (21 CFR Part 11, EU Annex 11, GAMP5) while supporting business teams in maintaining validated states and ensuring data integrity.
Key Responsibilities
- Quality & Validation: Define/maintain validated state of GxP systems, review CSV documents, identify process gaps, ensure data integrity.
- CSV Delivery: Plan/execute validation, ensure GDP/GMP/SDLC compliance, define risk-based strategies, review/approve test scripts, qualifications, and audits.
- Governance & Knowledge: Document learnings/incidents, improve processes based on feedback, audits, and regulatory changes.
- Site & Operations: Manage issues/change control, perform periodic system assessments, peer review validation records.
Site-Specific Projects
- Candidate should have experience in either or all of the below:
- Be able to perform CSV of manufacturing systems or lab instruments (e,g Windows 11 upgrade, Empower FR5 →10 upgrade UAT, DAC/LACE qualifications, connectivity checks, summary reports, master project validations), replacement of OpenLab ECM with Zontal SDMS (UAT, backup/verification schedules, protocols, summary reports).
- Enterprise Systems
- SCADA/ PLC/ DCS
- Other stand-alone systems.
Qualifications
- Bachelor’s/Master’s in Engineering, Life Sciences, or related field.
- 3-7 years’ experience in CSV/GxP IT systems.
- Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP5, GDP, GMP, SDLC.
- Excellent documentation, audit, and compliance skills.
- Strong analytical and communication abilities.
Contact details:
- Email: info@vitasci.com
- Subject: CSV Specialist
- Location Preference: Hyderabad | Bengaluru | Mumbai