Assistant Manager | Computerized system validation (CSV) | Pune | Cyber Strategy & Transformation
Deloitte (company site, opens in a new tab)PuneOn-siteDirect career pageEst. 12–20 LPA
Posted on 1 Sept
Your match
Against your primary resume
Log in to see your match score
Create a free account or log in to unlock your CV match score across:
- Role fit
- Experience
- Industry relevance
Reach people at Deloitte
People at this company you can reach
Log in to see who works here
Create a free account or log in to see the people at Deloitte you could write to:
- Recruiters & HR
- People in this function
- Work addresses
Protocol Intelligence
How competitive this role is
Competition
Background fit
Strictness
Log in to see why each signal reads the way it does.
Job description
Structured overview of role & requirements
About This Role
- Own end-to-end Computerized System Validation (CSV) projects ensuring compliance with client SDLC and regulatory frameworks.
- Manage assessments and validations related to GxP, 21 CFR Part 11, EU Annex 11, and ensure regulatory compliance.
- Act as subject matter expert for CSV and Quality Risk Management, coordinating incident management and change control processes.
Minimum Requirements
- Experience in computer system validation involving FDA regulated environments and cGxP compliance.
- Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 guidelines, and relevant quality regulations.
- Educational qualification: Graduate in BE/B.Tech (CS/IT/EC/E) or MCA from recognized university.
- Work Experience Required: Not explicitly mentioned in the JD.
Ideal Candidate Profile
- Demonstrated ability to manage and deliver multiple end-to-end CSV projects in regulated environments.
- Proficient in quality systems such as CMMi or ISO with deep understanding of validation and qualification processes.
- Skilled in coordinating cross-functional compliance activities and acting as CSV technical SME in Cyber Strategy contexts.