Overview
Quality Review Specialist Jobs in Bloemfontein, South Africa at IQVIA LLC
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Quality Review Specialist
Apply locations Bloemfontein, South Africa time type Full time posted on Posted Yesterday job requisition  R1463135
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 identification of trends on portfolio level.
Reviews the error rate on study level and contact study teams where applicable to discuss CAPA.
Liaise with Training Team to update training where needed. Independently bring solutions to the Quality Management Team. Provide comprehensive quality review expertise. Mentor junior Quality Review Staff.
REQUIRED KNOWLEDGE,
SKILLS AND ABILITIES
Medical terminology exposure
Excellent organizational,communication,leadershipand computer skills
Ability to exercise excellentattention to detail
Ability to act independently and with initiative required to resolving problems
Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIREDEDUCATIONAND EXPERIENCE
Bachelor’s degree, or educational equivalence, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 5 years’ experience in clinical trials within a similar function, including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle, including large trials >1000 patients; and including experience in handling customer negotiations (e.g. bid defence meetings); or equivalent combination ofeducation, training and experience.
PHYSICAL REQUIREMENTS
Extensive use of telephone and face-to-facecommunicationrequiring accurate perception of speech.
Extensive use of keyboard requiring repetitive motion of fingers.
Regular sitting for extended periods of time.
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Title: Quality Review Specialist
Company: IQVIA LLC
Location: Bloemfontein, South Africa
Category: Quality Assurance – QA/QC, Healthcare
