Position : Manager IT Validation
Reports to: Senior Manager
Location : Dewas/Taunsa
Industry : Pharma/IT
Qualification : BE/B.Tech with minimum 5 years of experience, preferably in Pharma Domain.
Job Profile:
- Support relevant IT projects by providing validation strategy and creating required validation deliverables.
- Reduce time taken to author validation documents by providing standard templates and unambiguous instructions/ guidelines.
- Work on harmonizing procedures across business areas to reduce duplication efforts.
- Ensures the execution of all processes complies with various worldwide regulations, e.g., GxP, 21 CFR Part 11, EU Annexe 11.
Technical Competencies required:
- Working knowledge and understanding of FDA/ ICH regulations in regulated environments such as 21 CFR Part 11.
- Computer System Validation.
- Ability to prepare, execute and analyze Validation Master Plans.
- Demonstrated knowledge of Quality Management Systems tools.
Swati Agnihotri
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