Validation Specialist - Pharmaceutical

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 guidances 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.