Computer System Validation CSV Data Integrity Compliance Spreadsheet Validation Project Management Risk Management Validation Engineer 21 CFR 11
5 to 6 Years
Healthcare / Medical / Hospital
Functional Area
Top Management

Job Title / Designation: Project Manager - CSV


Job Description:


Job Responsibilities:


·         Responsible for the Computer System Validation processes of the company

·         Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11).

·         Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.

·         Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply. 


Key Functions & Roles of the Candidate:


·         Must be willing to travel regionally and/or nationally throughout India 

·         Candidates must have excellent verbal communication and technical writing skills. 

·         Experience in generation and execution of protocols and procedures, related to different areas of qualification and validation

·         Candidates must demonstrate expertise in ISPE GAMP5, ICH Q8, ICHQ9, ICH Q10 and 21 CFR part 11, Computerized System Validation, Equipment Qualification and Validation Change Control

·         Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents.

·         Experience in execution of system validation lifecycle deliverables

·         Experience in project execution within at least one area of systems validation (e.g. Laboratory equipment, facilities utilities, manufacturing equipment)

·         Proficient in Microsoft Word, Excel, Power Point and Project

·         Ability to plan and manage own work

·         All candidates must be legally eligible to work in India


Specific Skill Set:


Minimum/Maximum/ Work Experience Required: 5+ Years

Education Qualification: Any Graduate

Job Location: Delhi

No of rounds of Interviews: 2

Number of Vacancies: 1

Work Timings: 8 AM - 5 PM

Travel & Allowance: Covered by QIC; depending on project requirements

Client Location: Aurangabad

Languages: Hindi, English (Mandatory); Additional languages preferred as well.


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Bangalore, Basavangudi
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