Manager - IT Validation - Pharma

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