Ecocareers · 1 day ago
Quality Assurance Computer System Validation (CSV)
West Point,, PA
Full-time
Onsite
Senior Level
5+ years expConfidential company is seeking a Quality Assurance Computer System Validation (CSV) professional. The role involves providing quality assurance support for SDLC deliverables primarily for Laboratory Instrument Systems, ensuring compliance with GxP operations, and leading validation teams to apply best practices in validation activities.
Staffing & Recruiting
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
Qualification
Required
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
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase