Job Description
Senior consultant
Job Summary
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Location: New Jersey
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Project role: Senior consultant
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Skills: Computer System Validation (CSV)
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No. of positions: 1
Job description:
New Billing, Exclusive, Committed
Alternate SR of 2487338
Request ID R331
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 guidementor 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, Compliancevalidation Plans, test protocols, Test Summary reports and ComplianceValidation 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 changesprojects simultaneously. Ability to provide Validation guidance, timely reviews, and escalations to TQ management. Hands on experience with validation of Data Solutions is preferred.
- To develop and deliver detailed solutions through consulting project activities
- To perform qualitative andoror quantitative analyses to assist in the identification of client issues and the development of client-specific solutions -
- To work with the team in implementing the solutions
- To develop good practice and Serve as a subject matter expert
- To design and structure reports and presentations that are appropriate to the characteristics or needs of the audience -
- To develop knowledge base by staying updated on industry best practices ,emerging trends and creating re-usable components.
Disclaimer
HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to secure@hcltech.com for investigation.