QA Manager, Quality Business System Administration

Brisbane  ‐ Onsite
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Keywords

Description

Position: QA Manager, Quality Business System Administration

Position Reports To: Associate Director, QA IT Systems and Compliance

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


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
  • Education Requirements:
    • 7+ years of relevant experience in a GMP environment related field and a BS or BA
    • 5+ years of relevant experience and a MS
    • Degree in Life Sciences or Computer related fields are required


To find out more about Real please visit www.realstaffing.com
Start date
01/2014
Duration
6-9 months
From
Real Staffing
Published at
12.01.2014
Project ID:
649804
Contract type
Freelance
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