Validation Specialist - Pharmaceutical Job at Tricon Solutions, Raritan, NJ

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  • Tricon Solutions
  • Raritan, NJ

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.

Job Tags

Contract work, Work experience placement,

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