Systems Validation Analyst
Onyx Pharmaceuticals, Inc. - South San Francisco, CA

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Under the direction of the Senior Manager, IT Systems Validation, the Systems Validation Analyst supports Onyx’s Computer Systems Validation program to assure the compliance, quality, integrity, reliability and performance of regulated computer systems. The position focuses on implementing and suggesting improvements for standard operating procedures and policies to meet US and international regulatory guidelines and industry best practices; guiding and training users inside and outside the department on the validation program; participating on project teams involving validated systems throughout the organization; and working within IT to develop and implement validation guidelines and procedures for applications and infrastructure validation projects. On a day to day basis, the position is also responsible for monitoring and enforcing change control polices to ensure computer systems are maintained in a validated state. Essential/Primary Duties, Functions and ResponsibilitiesSuggest and implement approved automation to improve and streamline technical processes.Identify process improvements across the work group to help increase compliance and security.Participate on validation projects and project teams as assigned.Drive and track validation deliverables from project team members and external vendors to ensure adherence to implementation deadlines.Assist in the development, review and approval of System Requirements Specifications, Risk Assessments, Validation Plans, Test Scripts, Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualifications (PQs) and Validation Summary Reports per Onyx procedures.Execute Test Scripts, Data Migration plans, and IQs/OQs/PQs in conformance with Good Documentation Practices.Review test results and work with development teams to perform root cause analyses and resolve test deviations.Ensure the accuracy, completeness and maintenance of computer system documentation and compliance records.Ensure validated computer systems remain in a validated state.Assist with the development, review, approval and tracking of change control records.Liaison with Quality to ensure documentation and procedures meet quality standards, applicable regulatory compliance and company guidelines/policies.Communicate status and activities within workgroup(s).Identify potential issues, develop resolution options and escalate with System Owner and IT personnel as appropriate.Proactively identify future needs related to GxP systems and work with System Owners in groups such as Regulatory, Drug Safety, Compliance, QA, Biostatistics and IT to develop project scopes and timelines.Keep informed of any regulatory changes (e.g., 21 CFR Part 11, Annex 11) that may affect computer system validation.Other Duties as assigned.Requirements Work Experience: Combination of a minimum of 2 – 5 years’ experience working in server administration and system validationMust have experience validating systems for compliance with 21CFR Part 11 and/or Annex 11Functional/Technical Knowledge & Skills: Demonstrated strong analytical, critical thinking and problem solving skills in making appropriate technical decisionsCustomer & Industry Knowledge: Strong knowledge of pharmaceutical/biotech industry and the overall drug development processEducation/Training: Bachelor's degree desirable (or equivalent work experience)Other Requirements: Outstanding customer service skillsExcellent verbal and written communication skills, analytical and problem resolution capabilities, and organizational and administrative skillsProven initiative, good judgment, and ability to achieve resultsAbility to work independently, as well as within a cross-functional team environmentAbility to work in a dynamic environment and manage competing prioritiesCompetenciesProblem Solving – Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; looks beyond the obvious and doesn’t stop at the first answersPerspective – Looks toward a broadest possible view of an issue/challenge; can easily pose future scenarios; can think globally; can discuss multiple aspects and impacts of issues and project them into the futurePlanning – Accurately scopes out length and difficulty of tasks and projects; breaks down work into the process steps; anticipates and adjusts for problems and roadblocks.

COMPLIANCE ACCOUNTABILITY: Consistently supports compliance and the Principles of Responsibility (Onyx Pharmaceutical’s Code of Conduct) by maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting non-compliance, and adhering to applicable federal, state and local laws and regulations, accreditation and licensure requirements (if applicable), and Onyx’s policies and procedures. - 2 years ago - save job
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Onyx Pharmaceuticals, Inc. (Onyx) is a biopharmaceutical company engaged in developing therapies that target the molecular mechanisms that...