Job Title - Validation Lead
Location - Raritan, NJ(Hybrid)
Job Type: Contract
Mandatory skills - Validation exp. Infrastructure and Tools - AWSAzure etc.
Key Responsibilities:
Candidates need to have hands-on experience in validating and implementing infrastructure systems and tools. e.g. AWS, Azure, JIRA, ServiceNow etc.
Any recent experience with divestitureseparation in J&J a huge plus. e.g. Manufacturing site cutovers (infrastructure and applications),
Ability to manage multiple dispositions for multiple J&J Managers with limited supervision.
Must have proven track record of Large Acquisitions & Separations. Strong CSV Expertise, especially within AcquisitionDivestitureSeparation.
Ability to manage end-end from Inventory, assessments, remediations to final dispositions 7-10 years of relevant experience has experience of leadingadvising Junior and Senior resources. Specifically in the Pharmaceutical, biotechnology, or medical device industry.
Experience in FDA andor 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, Compliancevalidation Plans, test protocols, Test Summary reports and ComplianceValidation Reports, SOPsWIs). 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 changesprojects simultaneously.
Ability to provide Validation guidance, timely reviews, and escalations to TQ management
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