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Location - Raritan, NJ(Hybrid)
Job Description (Posting).
Computer System Validation In addition to validation and regulation experience, the resource should have the following experience:
3-7 years of relevant experience; can work independently and guide mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA andor 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. Hands on experience with validation of Data Solutions is preferred.
(1.) To develop and deliver detailed solutions through consulting project activities
(2.) To perform qualitative andoror quantitative analyses to assist in the identification of client issues and the development of client-specific solutions
(3.) To work with the team in implementing the solutions
(4.) To develop good practice and Serve as a subject matter expert
(5.) To design and structure reports and presentations that are appropriate to the characteristics or needs of the audience
(6.) To develop knowledge base by staying updated on industry best practices ,emerging trends and creating re-usable components.
Skill (Primary): Domain Competencies (APPS)-Pharma Validation & Verification-Computer System Validation (CSV)
