Computer System Validation (CSV)

Katalyst Healthcares & Life Sciences-posted 6 months ago
Entry Level
New York, NY
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The Contractor, Quality Assurance – Computer System Validation (QA CSV) supports the on-going SAP projects. This involves working with cross-functional internal resources from Supply Chain, Regulatory, IT, Quality and external resources (third-party vendors, Implementation Partners etc.), to support SAP projects, version releases, Impact assessments and Periodic reviews. The incumbent works cross-functionally with internal departments and external resources on Quality-related issues like deviations and change controls. This position supports adherence to relevant regulatory requirements.

  • Writes and/or reviews and approves CSV documents including Validation Plans, Functional Risk Assessments, Application Design or Configuration Specifications, applicable Test Scripts.
  • Drives/participates in meetings with key stakeholders and provides key inputs in the validation process and the definition of deliverables.
  • Acts as the QA CSV point of contact and Subject Matter Expert (SME) for activities related to validation and Quality Risk Management for assigned GxP computer systems.
  • Assists and/or performs quality reviews and Quality Assurance (QA) vendor audits related to computer systems.
  • May assist in the management and/or oversight of other external resources for CSV-related activities.
  • Reviews system master plan for alignment with corporate requirements.
  • Performs GxP-related activities in alignment with business requirements and ensures compliance with applicable regulations.
  • Ensures evolving validation requirements are appropriately applied to CSV activities.
  • May write, contribute to or edit SOPs related to the validation of GxP computer systems.
  • May assist in the development of training materials related to the validation of GxP computer systems.
  • Works closely with IT and software/system vendor(s) to ensure user/design materials and test documentation are acceptable.
  • Applies knowledge of SAP User Interfaces, Cloud-based, SaaS systems, and interprets CSV regulations and guidelines.
  • Liaises with IT and other cross-functional business teams in the development of GxP/Non-GxP deliverables, SOPs, Work Instructions, Policies and other critical documentation.
  • Bachelor's degree in technical, scientific or other relevant academic discipline.
  • Minimum of 6 years of experience in a pharmaceutical, biotechnology or related environment.
  • Minimum of 3 years of experience in GxP Computer System validation or equivalent experience and/or education.
  • Experience with SAP projects is required.
  • Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or other relevant regulatory authority regulations and guidance related to CSV.
  • In-depth knowledge of relevant CFR (Title 21), FDA and ICH guidelines including GCP, GLP, and GMP policies and procedures.
  • Demonstrated ability to lead and perform computer system validation activities.
  • Experience in working with cross-functional teams within the organization along with third-party Vendors and Implementation Partners.
  • Ability to influence without direct authority.
  • Proficiency with Microsoft Office and Project Management Tools.
  • Excellent verbal and written communication skills.
  • Ability to work independently and collaboratively in a fast-paced, matrixed, team environment.
  • Analytical thinker with excellent problem-solving skills.
  • Excellent planning, organization and time management skills.
  • ASQ CQA certification is desired but not a must.
  • Experience working on SAP or equivalent is desired.
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