FDA (Food & Drug Administration)

FDA (Food & Drug Administration)

Oloop Technology Solutions Private Limited
Mumbai India
6 - 9 Years
Not Specified

Job Description


Job Description :
Overview
Hello Team
Please start working on below requirement.
Exp – 6 to 9 yrs
Location – Mumbai
Capgemini
C2H
Notice period : 15 -30 Days Max
Role requirements:
To be successful in the role you will need some previous CSV experience to be able to drive CSV results with Business stakeholders, Development team and coordinate with Test team to review and complete assigned validation tasks and deliverables on multiple GxP systems.
Main requirements:
• FDA (Food & Drug Administration) CSV (Computer Systems Validation) SME
• Experience in FDA 21 CFR 11 testing compliance must-have
• Participates in design and implementation of QA test strategies
• Hand-on experience in CSV process compliance
• Knowledge of SQA process compliance
• A team player with an ability to push forward CSV compliance agenda in JnJ while educating the teams
• Work with team, train them on CSV compliance and testing methodology
• Ability to coordinate with Business users, development and Test teams
• Ability to communicate effectively both orally and in writing
• Strong analytical, problem-solving and conceptual skills
• Excellent organizational skills; attention to detail
• Ability to identify and resolve project issues effectively and efficiently
Candidates should be flexible / willing to work across this delivery landscape which includes and not limited to Agile Applications Development, Support and Deployment.
Your role as a CSV Specialist will involve:
• Acting as a control point for validation documentation for FDA regulated systems
• Consultation regarding quality and compliance with FDA regulations - CFR 21 (Part 11)
• Training delivery to employees on FDA and quality related queries
• Working in highly regulated environment
• Coordination of various quality and compliance requirements
• Providing variance reports
• Supporting deviation management

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