GXP Qualification & Validation Specialist

  •  

Calipatria, CA

Industry: IT Consulting/Services

  •  

11 - 15 years

Posted 289 days ago

  by    Emily Russo

This job is no longer available.

We are looking for GXP Qualification & Validation Specialist for our client in  Foster City, CA

Job Title: GXP Qualification & Validation Specialist

Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire

Job Description:

KEY RESPONSIBILITIES:

  • Provide SME supportInfrastructure and Tools qualification for ongoing Changes and major/minor programs.
  • Perform IQ/DQ/OQ/PQ as required for the Infrastructure and associated tool components
  • Provide strategic guidance & support for GxP qualification compliance controls for Networks, Operating Systems, Cloud, Infra & Security tools
  • Adhere to the Client QMS and associated templates and protocols.
  • Interact with Project team and client?s QA team for schedule adherence to timelines and deliverables
  • Develop and perform qualification protocols in compliance with regulations and write qualificationreports
  • Interact with Global (Onsite/Offshore) teams for coordination of qualification activities and report compliance to the client
  • Responsible for development and enhancements of GRC services, team and delivery capabilities.
  • Conducting regular trainings and knowledge base for the team

SKILLS?:

  • ??10+ years of industry experience including Infrastructure???Qualification, Infra/Security Tools qualification, computer system??validation, SDLC & QA experience.
  • Experience working in a Pharma environment with GxP systems.
  • Hands on experience working on projects related to 21 CFR Part 11,??Part 58, Part 210, Part 211 and Part 820.
  • Experience working on GAMP 5qualification/validation model
  • Experience working in SDLC methodologies (waterfall, agile, spiral)??including change management.
  • Experience in documentation of pharma quality management??systems.
  • Excellent written and communication skills including thorough??knowledge of Good Documentation practices.
  • Experience in managing and conducting change control,??qualification/validation planning and summarization.
  • Experience with software such as document management and??automated testing tools like Documentum.
  • Preferredexperience working on complex data center and??infrastructurelandscape.
  • Experience handling complex and diverse Infrastructurelandscape.

?QUALIFICATIONS?:

  • ?Minimum bachelors degree in science or technology
  • CISA/CGEIT/CISM/CISSP