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CSV Analyst / Validation Analyst | Raritan, NJ / New Brunswick, NJ| Contract

Hybrid in Raritan, NJ, US • Posted 3 days ago • Updated 3 days ago

Contract Corp To Corp

Contract W2

Contract Independent

12 Months

Hybrid

Depends on Experience

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Job Details

Skills

GxP
Computerized System Validation
Regulatory Compliance

Summary

Hi ,

Greetings !

We do have opening for our client,

Role : Validation Analyst

Location : Raritan, NJ / New Brunswick, NJ

Duration : Long-term Contract

Job Description :

Candidates need to have hands-on experience in validating and implementing infrastructure systems and tools. e.g. aws, azure, JIRA, ServiceNow etc.

Any experience with divestiture/separation a huge plus. e.g. Manufacturing site cutovers (infrastructure and applications),

Must be able to work out of Raritan or New Brunswick Office atleast 3 days a week.
Must be able to Independently Lead Business Separation activities for Large global & regional GxP Computerized systems. With minimal supervison.
Recent experience with Acquisitions/Separations/Divestiture huge plus. Strong CSV Expertise, especially within Acquisition/Divestiture/Separation.
Ability to manage end-end from Inventory, assessments, remediations to final dispositions; Infrastructure Qualifications & Business Systems Validations 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: 91172365
Position Id: 9069118
Posted 3 days ago

Contact the job poster

Shalman Mohamed Aniba

Recruiter @ Healthcare Triangle Inc

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