Validation Specialist Pharmaceutical Apply
Location: Raritan, NJ Hybrid
Type: 12 months+ contract
Job Details:
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10+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area
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Has working experience in any one or two of the following domains -Clinical Development and Supply Chain, Drug Discovery, MES, QMS, LIMS, Data Integrity Platforms
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Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC
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Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams
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Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner & Business users / SME) and interpret business rules and requirements and documents them for software development.
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Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy / Test Planning, Validation / Test Summary, Requirement Trace Matrix.
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Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner & Business users / SME) and interpret business rules and requirements and documents them for software development.
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Should be able to handle and guide multiple GxP projects
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Ability to work with project team to facilitate interaction between Project team and Business Stake holders.
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Ability to manage and provide guidance / train the team on Policies, end to end SDLC Process, Procedure and Tools
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Trains the project team on the relevant procedures associated with different SDLC processes and Tools
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Strong in Project Management tools like JIRA
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Manage Project priorities based upon identified risks.
