Quality Assurance Computer System Validation

Catalyx • Upper Gwynedd Township, PA

2d

About The Position

Catalyx is seeking a Quality Assurance Computer System Validation (CSV) to play a pivotal part in ensuring the compliance and efficiency of computerized systems within the new facility, contributing to the successful implementation of our operations.

Requirements

• 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.
• Ability to prioritize and manage multiple initiatives, projects concurrently.

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 team’s progress and accomplishments on instrument validation activities ensuring project remains on target for key milestones.

Benefits

• At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them.
• The team in Catalyx benefits from a Total Rewards package.
• This includes great personal benefits and professional growth opportunities.
• Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.
• At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 501-1,000 employees