Quality Assurance Specialist

A manufacturer and supplier of diagnostic products is looking for a Quality Assurance Specialist to join their team in Pinetown, Durban.

The successful incumbent will be required to support the company’s mission, vision, core values, and quality management system through the implementation and maintenance of a formal corrective and preventive action program, as an extension of the company’s existing notification system, to ensure adherence to the various strategic, business, and regulatory requirements. To investigate incidents, deviations, out-of-specification results, and customer complaints; perform root cause analyses, suggest, and implement corrective and preventive actions, and monitor effectiveness in compliance with the company’s quality management system, cGMP, and regulatory requirements.

To evaluate the impact of incidents, deviations, out of specification results, changes, and customer complaints by facilitating the execution of risk assessments for such instances, in conjunction with subject matter experts where required. Ensure that risk assessments are completed, filed, and reported on when required. The responsibilities will further include, but are not limited to, maintaining formal CAPA programme and effectiveness monitoring of CAPAs implemented, conducting investigations and root cause analyses, risk assessments and impact evaluation, supporting the applicable notification systems, and Quality Assurance Systems and general department support.

Key Requirements: Bachelor’s degree in Chemical Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related field with at least 3 years’ experience in the pharmaceutical manufacturing environment, with working knowledge of pharmaceutical facilities, processes, equipment, laboratories, and systems required. Experience in biotechnology or biopharmaceutical manufacturing is preferred.

Additional Requirements: Knowledge of Quality Management system regulations and standards, e.g., ISO
9001, ICH
10, ISO
13485; project management skills; experience with electronic systems, such as SAP-QM and Trackwise; robust knowledge of Microsoft Excel and/or other trending tools; ability to work with individuals across all levels of the company, including management; and hands-on experience with Quality Management systems, especially on monitoring of CAPA, performing root cause analysis, investigations, and risk assessments.

* Only candidates that meet all the requirements should apply

** Only candidates that are shortlisted will be contacted

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