Validation Lead

Hybrid in Raritan, NJ, US • Posted 1 hour ago • Updated 1 hour ago
Contract W2
12 Months
50% Travel Required
Hybrid
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Validation
  • ai
  • GxP

Summary

Role - Validation Lead

Location - Raritan, NJ(Hybrid)

Key Responsibilities

  • Candidates need to have hands-on experience in validating GxP GEN AI based solutions and LSMV Safety and Pharmacovigilancesystem
  • Ability to manage multiple dispositions for multiple J&J Managers with limited supervision.
  • Ability to manage end-end from Inventory, assessments, remediations to final dispositions; 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources. Specifically in the Pharmaceutical, biotechnology, or medical device industry.
  • Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation; Define and implement Risk based validation activities.
  • 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, SOPs/WIs). 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.
  • 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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10200946b
  • Position Id: 9100002
  • Posted 1 hour ago
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Vipin Kumar

Recruitment Manager @ Nityo Infotech Corporation
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