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IT Quality / Validation


Location: Burlington, Massachusetts
Job Category:

Location: Burlington, MA

Duration: 3+ Months

IT Quality Analyst

We are looking for an IT Quality Analyst with experience using MasterControl QEM / QMS hosted solution.  The validation phase will include PQ protocol generation, dry runs and execution. CAPA, Change Control, Complaints and Deviations tested and implemented in sequential phases.  

Requirements

• Bachelor's/Master's Degree

• 7+ years IT Quality / Validation experience in computerized
system validation within a regulated environment preferably R & D application.

• Thorough knowledge of GxP and ERES (21CFR Part 11 and Annex
11) regulations and guidelines

• Detailed knowledge of the IT system development life cycle and
software quality assurance in a regulated environment

• Thorough knowledge of IT Controls methodologies, including
GAMPS and ITIL

• Experience with risk analysis and risk management practices and tools

• Excellent communication skills, both verbal and written

• Knowledge of general software, database concepts and Data Integrity

• The ability to work both independently and with teams


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