Job Summary

• If possible with previous J&J experience: 3-7 years of relevant experience; can work independently
• Experience in the Pharmaceutical, biotechnology with Manufacturing systems used in CAR-T therapy related System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
• Ability to Review Automated Test script Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.

Ability to provide Validation guidance, timely reviews, and escalations to TQ management. 

Key Responsibilities

1. To develop and deliver ,detailed solutions through consulting project activities
2. To perform qualitative and/or quantitative analyses to assist in the identification of client issues and the development of client-specific solutions
3. To coordinate with Internal and external stakeholders to ensure effective deliver of client specific solution
4. To design,structure and deliver reports and presentations that are appropriate to the characteristics or needs of the audience
5. To cultivate successful customer relationships

Skill Requirements

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Other Requirements

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