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
- 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
- ??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.
- ?Minimum bachelors degree in science or technology