Job ID :
3810
Company :
Internal Postings
Location :
foster city, CA
Type :
Hire
Duration :
6 months
Status :
Active
Openings :
1
Posted :
5 years ago
Job Seekers, Please send resumes to resumes@hireitpeople.com
  • Argus Safety 7.0.x Upgrade from 5.0.
  • 2+ years with validation of drug safety systems.
  • At least one year of hands -on experience with Argus 7 highly desirable.
  • Experience with data migration validation/testing.
  • Minimum of 5 to 6 years experience in Quality and Compliance with substantial hands-on computer system validation experience.
  • Prior experience leading/mentoring other validation professionals
  • Prior experience working with offshore teams.
  • Experience in FDA regulated environment with good understanding of GxP related processes including Risk Based validation.
  • Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
  • Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols,
  • Test Summary reports and Compliance/validation reports.
  • Experience in Software Development Lifecycle (SDLC).
  • Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
  • Experience with in Change Control processes.
  • Experience with various FDA regulations (e.g. 21 CFR Part 11, 210, 211, 820)
  • Experience is creation of SOPs.
  • Knowledge of FDA guidance’s and industry standards (i.e., GAMP).
  • Hands- on experience in HP Quality Center and QTP.
  • Strong verbal and written communication skills.                                                    
  • Perform assessments of computer systems and processes at client sites (compliance with internal procedures, industry best practices, and regulatory requirements)
  • Develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports