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The Planet Grouphttps://cdn.haleymarketing.com/templates/63515/logos/theplanetgroup-200x200.pnghttp://www.theplanetgroup.comhttp://www.theplanetgroup.comtrue
Posted: 07/25/20242024-07-252024-09-08Employment Type:ContractJob Category:QA/AutomationJob Number: 619794Is job remote?: No
Job Description
Sr. IT Qualification Engineer
Provide independent technical leadership and accountability for overall IT Infrastructure Qualification and CSV efforts
Ensure quality and compliance is met in accordance with established procedures and standards of the Quality Systems by applying critical thinking on qualification and validation work
Plan, generate, review and/or approve qualification or validation packages for IT Infrastructure or GxP systems in support of compliance activities
Develop or assist with change controls, CAPAs, deviations, exceptions required as part of qualification/validation efforts
Engage with IT stakeholders in supporting continuous improvements to the existing procedures and policies in relation to compliance and update those as necessary
Perform gap analysis & necessary remediation efforts on current IT Infrastructure to ensure compliance with Part 11 and Annex 11
Collaborate/lead/participate in decision making and make recommendations regarding best options for qualification of computerized systems. Maintain close communication with stakeholders and team members to keep apprised of IT Infrastructure needs, & impact on GxP processes or operations
Collaborate with Revance approved vendor personnel in coordinating qualification or validation efforts to ensure successful system implementations
Perform system assessments based on version upgrades/release updates on SaaS/Cloud based GxP systems and ensure all the required verification and validation efforts are performed per the assessments conducted
Facilitate the computer system validation risk assessments i.e. System level, Requirement level risk assessments, & System and Data Audit Trail assessments etc.
Assist IT staff with business process deliverables such as process flows, data flows, user/operating procedures, work instructions and forms for GxP computerized systems
Perform System Periodic Reviews ensuring that the systems are maintained in their validated state
Support Regulatory inspections and internal and partner audits, and implements corrective actions as needed in CSV
Skills:
Minimum of seven (5-7) years or more in the pharmaceutical industry with GMP experience
Understanding of Validation Life Cycle approach and practical working knowledge of computer system validation/computer software assurance requirements
Knowledge of infrastructure qualification or validation of computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10
Demonstrate ability to effectively manage multiple projects/priorities and good understanding of SDLC phases and phase gates
Experience with EDMS, VLMS, LMS and working knowledge of IT Infrastructure systems (AD, Backups, VMware, Monitoring at minimum)
Demonstrate excellent written and oral communication skills.
Effective time management and interpersonal skills.
Must work effectively within teams with rapidly changing priorities.
Demonstrates analytical problem-solving skills.
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet domain (@theplanetgroup.com or @launchcg.com) - and not a domain with an alternative extension like .net, .org or .jobs.
The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
Explore exciting job opportunities in and around Newark, California! Situated in the heart of the San Francisco Bay Area, Newark offers an unbeatable blend of career advancement and quality of life. With easy access to Silicon Valley and major tech companies, as well as the cultural delights of nearby Berkeley and Oakland, this area is a magnet for innovative professionals. Enjoy the stunning views from Mission Peak Regional Preserve, indulge in diverse cuisines along the Niles Canyon Railway, catch a show at the Fremont Center for the Arts, or cheer on the San Jose Earthquakes soccer team at Avaya Stadium. Discover why Newark, CA is the perfect place to grow your career and explore new horizons!
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