Associate Quality Review Specialist
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Job Location:
Bloemfontein - South Africa
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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.
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; or equivalent combination of education training and experience
PHYSICAL REQUIREMENTS
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
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
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
