Quality Assurance Officer

6 days ago


Rustenburg, South Africa The Aurum Institute Full time

**Work Description**

The Quality Control Officer is responsible for conducting, implementing and managing all quality control and assurance related activities including managing the review systems facilitating the collection of quality data. The Quality Control Officer oversees that all processes contributing to the performance of a clinical trial are conducted in compliance with the applicable regulatory requirements, protocols, ICH GCP Guidelines and South African Guidelines.

**Technical Work Responsibilities**
- Implement quality control and assurance standards
- Evaluate adequacy of internal quality control and assurance standards
- Develop sampling procedures for recording and reporting quality data
- Review the efficiency of quality and inspection systems
- Document internal audits and other quality assurance activities
- Investigate and resolve all non-conformance issues
- Collect and compile quality statistical data
- Analyse data and identify areas for improvement in the quality system
- Develop, recommend and monitor corrective and preventive actions
- Prepare reports to communicate the outcome of all quality activities
- Identify training needs and schedule training interventions to address the requirements for all quality standards
- Coordinate and support on-site audits conducted by external providers
- Evaluate audit findings and implement appropriate corrective actions
- Monitor risk management activities
- Oversee document management systems
- Comply with all quality and industry regulatory requirements

**Work Experience**:

- At least 2 years’ clinical research experience in HIV/AIDS, Covid-19 and TB
- Previous At least 3 years’ experience in quality assurance

**Minimum requirements**:
**Qualification**
- Grade 12.
- Post-Matric Qualification: Bachelor’s Degree in Health, Science or Social Sciences.

**Advantageous**:

- Certificate of Competence in Quality Assurance Techniques or Similar
- ISO 9001 QMS Certificate
- Valid GCP Certificate

**Other Requirements**
- Overnight travel (up to 10%) by land or air when required
- Valid Driver’s License
- Own Vehicle
- Proficient in verbal and written English
- Advanced computer skills

**Skills required**
- Good communication skills.
- Ability to solve practical problems.
- Good management and interpersonal skills.
- Proficient in written and spoken English and fluency in local languages.
- Ability to work independently and in a team.
- Ability to work under pressure
- Ability to follow deadlines, accuracy, documentation, and attention to detail.

Kindly provide current and relevant references for background checks


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