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Validation Specialist in CSV

2 months ago

Chula Vista, California, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • Collaborate with project managers and client teams to grasp the overarching goals of projects.
  • Develop validation strategies, user requirement specifications, system design documents, risk evaluations, testing protocols, traceability matrices, data migration strategies, and change documentation.
  • Create and assess testing strategies and scripts (IQ/OQ/PQ), implement test plans, compile test summary reports, and finalize validation documentation.
  • Oversee and uphold electronic records within the client’s document management framework to ensure adherence to regulatory standards.
  • Assist in the upkeep and upgrades of the client’s bespoke integration between Veeva QualityDocs and Cornerstone.
  • Engage with client personnel to verify that validation activities and outputs align with corporate policies and procedures.
Essential Qualifications:
  • Bachelor’s degree from an accredited institution; advanced degrees and relevant certifications (e.g., PMI-PBA, CAPM, PMP) are highly valued.
  • Minimum of 5 years of pertinent experience in a computer system validation (CSV) capacity within the biotech or pharmaceutical sectors; familiarity with relevant regulations and guidelines (e.g., Title 21, GxP) is preferred.
  • At least 3 years of relevant experience with Cornerstone On Demand; additional experience with Compliance Wire, Veeva Quality Docs, SQL, and Python is advantageous.
  • Strong foundation in project management and system validation practices, with the ability to set and manage expectations effectively.
  • Proven capability to manage multiple projects and prioritize tasks to achieve quality outcomes.
  • Comprehensive understanding of a Risk Management-Based Approach to system validations, including system risk classifications and system categories (GAMP 5).
  • Familiarity with 21 CFR Part 11 and Annex 11 regulations.
  • Knowledge of regulations concerning personal and patient data privacy (GDPR).
  • Experience in leading validation initiatives.
  • Proficient in authoring validation strategies, user requirement specifications, system design documents, traceability matrices, testing plans and scripts (IQ/OQ/PQ), executing test plans, compiling test summary reports, and preparing final validation documentation.
  • Experience with Electronic Document and Quality Management Systems such as Veeva, Qualio, or Master Control is highly preferred.
  • Background in test coordination and management, including training users on executing test protocols and overseeing test results throughout the process.