Be the Quality Reviewer and Approver of Automation System Development Lifecycle documentation (Requirements Specifications, Configuration Specifications, Test Plans, Requirements Traceability Matrices, Automation Change Controls) in the pharmaceutical regulated environment.
- Understanding of FDA regulations/guidance, various GAMP guidance documents, along with V model, 21CFR part 11 and other approaches to System Development Life Cycle (SDLC) validation
- Providing Quality oversight of all computer system validation activities so that they can be completed on schedule and in compliance with local procedures and industry standards.
- Responsible for effective document review and Quality approval in accordance with client Manufacturing Standards, Client Quality Policies, cGMPs for the generation of Quality Assurance Plans, Requirements specifications, Design Specifications, and Test Protocols
- Experience with Quality systems including change control, incident management, and deviation management
- Familiarity with the following systems preferred: PAS-X, DeltaV, PI, Rt Reports, BAS, and SAP
- Effective global communication skills (both written and oral)
- Strong analytical and problem solving skills
- Ability to multitask and manage/prioritize multiple projects and deadlines
- Strong customer service focus
Education: B.S. Degree required
Duration: 6+ months (40 hours per week)
Start Date: December start date
Remote: CSV Review Contractor (232109)