Jobs

Interviews
Job Alerts
Tools

Upskill and Grow with AI

Mock Interview Practice interviews in realistic simulations

Coding Practice Improve your coding skills with challenges

Certification Earn certifications to validate your skills

AI Learning Get trained with AI expert sessions

Career Path AI insights for smarter career decisions

AI Job Match Score AI-Powered Job Match Against Your Resume and Optimize Your Resume

Career Tools and Resources

Resume Builder Build Professional Resume with Ease

ATS Friendliness Check Check Resume Friendliness for Applicant Tracking Systems

Auto Apply Apply to hundreds of jobs on any platform effortlessly

Co-Pilot (Chrome Extension) Your AI Assistant for Seamless Browsing Efficiency

Interview Questions Streamline interviews with ready-to-use questions

Salaries Discover market-driven salary insights across skillsets and geographies

Companies Explore leading companies actively hiring talent
For Employers

Home
>
Jobs in nanjangud
>
Jubilant Biosys
>
Associate Director - CSV

Associate Director - CSV

Jubilant Biosys

18 - 23 years

20 - 25 Lacs

nanjangud

Posted:3 days ago| Platform:

Apply

Skills Required

organic chemistry equipment qualification aerospace pharma risk assessment consulting oncology life sciences test cases monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible to harmonize, ensure and standardize policies and procedures for computerized system validations and ensure effective implementation of the computerized system validation in coordination with corporate quality and with all departments of the plant with respect to Computer System Validation (CSV)

Responsible to assist site personnel/management in developing protocols, test cases, validation packages, etc for validations of computerized system

Responsible to evaluate validation requirement for computerized systems used for GxP purposes in various department of the plant

Provide guidance on the interpretation of regulatory requirement and guidelines for GxP Computerized systems from regulatory agencies and organizations in relative to CSV/ IT Compliance activities

Responsible to review of CSV requirements in the validation protocols by defining the required test cases of IQ/OQ for computerized system of equipment s & instruments etc, and also tracking of CSV implementation

Ensure the compliance-related issues handled independently aligned with the processes and controls on computerized systems

Responsible to identify, communicate and manage compliance risks, breaches and issues, and monitor corrective action to mitigate the risk through risk assessment related to computerized systems

Responsible to independently assess the regulatory compliance activities of computerized system eg GxP, FDA, Annex 11 etc

To conduct internal reviews and compliance at site on GxP Computerized systems

To assess and improve the cGMP practices and procedures on computerized system validations

Responsible for data governance & management controls in reviewing complete, consistent, accurate, truthful and reliable data in all GxP Computerized systems required as per regulatory requirements

Ensure all incidents related computerized systems are logged, tracked, monitored and closed after it has been detected

Review and approval of equipment qualification and re-qualification documents and monitoring of equipment, utility and facility qualification activities

Review and approval of equipment layouts and Piping & Instrument Diagrams (P&IDs)

Review and approval of Qualification Summary Report for the equipment

Review of the engineering documents associated with SOP s

Review of VMP schedules of qualification

Responsible for review and guiding Quality Risk Managements related to Computerized Systems, Equipment qualification, Utility qualification and facility qualification

Responsible for review, monitoring and guiding Quality Management system such are Change controls, events/deviations & CAPAs in Track wise related to CSV, Equipment qualification, Utility qualification and facility qualification

Ensure all CAPAs related to Computerized system, Equipment qualification, Utility qualification and facility qualification are closed as per the CAPA specified time lines

Coordination and implementation of CAPA for all internal / external audit observations related to CSV, Equipment qualification, Utility qualification and facility qualification

More Jobs at Jubilant Biosys

Research Associate II

Bengaluru

3 - 5 yrs

INR 5 - 7 Lacs

Territory Manager

Mysuru

2 - 7 yrs

INR 4 - 9 Lacs

Officer

Noida

3 - 4 yrs

INR 5 - 6 Lacs

Research Associate I-Analytical

Noida

1 - 4 yrs

INR 3 - 6 Lacs

Trainee Research Associate - ANALYTICAL

Noida

1.0 - 3.0 yrs

Salary: Not disclosed

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now

Jubilant Biosys

Research Services

Noida Uttar Pradesh

Login to

Please Verify Your Phone or Email

Confirm Action

Associate Director - CSV