Quality Review Specialist
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Job Location:
Bloemfontein - South Africa
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
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 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 leadership and computer skills Ability to exercise excellent attention 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 REQUIRED EDUCATION AND EXPERIENCE
Bachelors 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 of education training and experience.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
