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Specialist, Computer Systems Validation, Quality Assurance Validation

Company: Catalent Pharma
Location: Madison
Posted on: October 11, 2018

Job Description:

Job Description Specialist, Computer Systems Validation, Quality Assurance Validation Position Summary Catalent is looking to recruit a Specialist, Computer Systems Validation, Quality Assurance Validation to join a growing team in Madison, WI. The Specialist, Computer Systems Validation, Quality Assurance Validation position shall provide validation support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced and/or modified in a cGMP Manufacturing Facility as well as its related support areas, which may include Facilities/Engineering, Quality Assurance, Supply Chain, and Quality Control. The Specialist, Computer Systems Validation, Quality Assurance Validation is responsible for generating, reviewing and approving system assessments, test scripts, change controls, process improvements and compliance governance at all applicable points of the system life cycle. In addition, this individual will serve as the subject matter expert to provide compliance leadership and oversight for CSV projects. They will collaborate with business partners to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes. In concert with Catalent's Patient First philosophy, this role ensures that regulatory compliance is maintained for the implementation of new systems and changes to existing systems which are used for the manufacture of drug products. This position shall provide support for computerized systems, software, and IT infrastructure systems which are essential in the manufacture of quality products. These products are delivered for use in our customer's clinical studies, which promote future marketed medicines. The Role

  • Leads computer system validation efforts related to authoring and executing specifications and validation documentation for equipment/systems, in alignment with Good Manufacturing Practices (GMPs), FDA 21 CFR Part 11 and Annex 11. Validation documentation includes Validation Plans, Requirement Specification, Risk Assessments, Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Business Continuity Plans, Disaster Recovery Plans, IQ/OQ/PQs, Requirements Traceability Matrices (RTM) and Summary reports.
  • Serves as the SME for Computer System Validation and maintain knowledge and information in the Computer System Validation area of expertise.
  • Reviews computer system validation documentation, to ensure data integrity requirements are maintained.
  • Tracks and resolves discrepancies/deviations during qualification activities.
  • Prioritizes qualification activities in line with the project schedules and timelines.
  • Coordinates validation/qualification activities with key stakeholders.
  • Provides direction to validation contractors to complete on-site validation (if required). The Candidate
    • BS in computer related field.
    • 5+ years of working Computer Systems Validation experience in the Pharmaceutical, Biotechnology or Medical Devices industry.
    • Must have knowledge of GxP, regulatory requirements for computerized analytical systems validation (i.e. 21 CFR part 11), disaster recovery and good documentation practices.
    • Experience in authoring, reviewing and approving of validation deliverables including Risk Assessments, Requirements, Test Plans, Protocols, Traceability Matrix, Reports, Summary Reports and Standard Operating Procedures (SOPs). Catalent's standard leadership competencies that are used to interview and for Performance & Development:
      • Leads with Integrity and Respect
      • Delivers Results
      • Demonstrates Business Acumen
      • Fosters Collaboration and Teamwork
      • Champions Change
      • Engages and Inspires
      • Coaches and Develops Position Benefits
        • Potential for career growth within an expanding team
        • Defined career path and annual performance review & feedback process
        • Cross functional exposure to other areas of Catalent
        • Medical, Dental, Vision, and 401K are all offered from day one of employment
        • 19 days of paid time off annually + 7 paid holidays About Catalent Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Catalent. More products. Better treatments. Reliably supplied. --- Visit to explore career opportunities. Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to . This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

          Keywords: Catalent Pharma, Madison , Specialist, Computer Systems Validation, Quality Assurance Validation, IT / Software / Systems , Madison, Wisconsin

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