Quality Assurance Computer System Validation (CSV)

Roles & Responsibilities: Responsible for providing quality assurance support and oversight for System Development Life Cycle (SDLC) deliverables of primarily Laboratory Instrument Systems and secondary for Application Systems support GxP operations Collaborate with cross-functional team to define risk-based approaches for computer system validation activities and testing. Lead validation teams to a better understanding of validation best practices and applying quality principles. Reviews various GxP deliverables for conformance with SDLC baseline criteria and other internal and external regulations. Identifies and resolves issues interfering with execution of deliverables. Enforces Good Documentation Practices and ensures that SDLC deliverables are properly cataloged and available for internal and external regulatory inspection. Provide additional support with SDLC deliverables for Enterprise Application support, as applicable. Perform Supplier Assessments to ensure vendor compliance to regulations and standards before introducing instruments or applications into the lab environment. Attend meetings as quality representative and capture meeting minutes, escalating items as appropriate. Oversee teams progress and accomplishments on instrument validation activities ensuring project remains on target for key milestones Education & Experience: 5-8 years of experience working in a Pharmaceutical/Biotechnology industry; experience working in a health authority regulated (e.g. GxP) environment Industry experience including computer system validation, System Life Cycle (SLC), software validation, and/or Quality Assurance functions. High level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US Food and Drug Administration High level of expertise in SLC methodology (e.g., V-model, waterfall, agile, spiral) including change management. Extensive experience providing oversight for adherence to enterprise SLC and procedures. Experience in creation, execution, and reviewing a change control document. Proficient skills dealing with and understanding typical laboratory facilities and equipment. multiple initiatives, projects concurrently.

Created: 2026-03-04