Computer System Validation (CSV)

Katalyst Healthcares & Life Sciences • New York, NY

247d

About The Position

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.

Requirements

• 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.

Nice To Haves

• ASQ CQA certification is desired but not a must.
• Experience working on SAP or equivalent is desired.

Responsibilities

• 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.

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree