Description
Essential Duties and Responsibilities:- Maintain system administrative and day-to-day support functions for Quality Enterprise IT systems such as LiveLink EDMS, Pilgrim QMS and ComplianceWire LMS
- Interface with vendors and IT to address and resolve system issues and appropriately communicates gating items to management, Business Process Owners and users
- Lead the development and validation of software implementation projects involving existing or new systems to improve the overall accuracy, efficiency, and effectiveness of the business processes
- Drive the analysis, development, testing, validation and deployment of configuration, workflow, reporting and/or software updates
- Assist in end user training on Quality Enterprise IT systems as needed
- Participates in the continuous improvement and development of Quality Systems to ensure quality and adherence to cGMPs; Supports the development and management of quality metrics to optimize performance, productivity, effective resource planning, and management review
This contractor resource is needed to lead the Pilgrim Phase 2 (Audit Module) project from the QA perspective, as well as provide routine day-to-day administrative system support for existing Quality IT systems such as eLink, CANVAS, and ComplianceWire.
Experience:
- Minimum 5 years of experience in Quality Assurance
- Minimum 2 years of Business System Administration of Quality Enterprise IT software systems
- Minimum of 5 years in the pharmaceutical, biotech, diagnostics, medical device or healthcare industry
- Knowledge of cGMP and ICH guidelines
Skills/ Training/Education:
- Required Technical Skills:
- Demonstrated knowledge and experience with the administration of Quality Enterprise IT software systems
- Working knowledge of relational database management systems such as Oracle and MSSQL
- Strong knowledge of applicable Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH)
- Strong knowledge of 21 CFR Part 11 and Annex 11 Regulations
- Experience in implementing and maintaining GXP computer systems in a validated state with the ability to assess compliance risks