Job Description

PURPOSE

Quality Reviewer

RESPONSIBILITIES

Conduct internal Data Management Quality Reviews in order to fulfil business unit, customer and regulatory authority requirements and expectations.
Ensure that re-occurring findings/errors are communicated effectively with operational team.
Participate in review of corrective/preventative actions.
Assure recording of an appropriate response to any non-compliance, with corrective action and a timeframe for completion.
Oversee the documentation and reporting quality/compliance issues, relating to the product, process or quality system, to Management within specified regional timelines.
Collect and report quality metrics as required to Management.
Maintain working knowledge of current applicable regulatory and Sponsor guidelines and related review techniques.
Reviews aggregated information provided on the QRP and performs analysis and identificati...