Job Description

Location: Raritan, NJ – Hybrid

Type: 12 months+ contract

Job Details:

• 10+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area

• 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

• Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC

• 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

• 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.

• 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.

• 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.

• Should be able to handle and guide multiple GxP projects 

• Ability to work with project team to facilitate interaction between Project team and Business Stake holders.

• Ability to manage and provide guidance / train the team on Policies, end to end SDLC Process, Procedure and Tools

• Trains the project team on the relevant procedures associated with different SDLC processes and Tools 

• Strong in Project Management tools like JIRA

• Manage Project priorities based upon identified risks.

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