Quality Assurance Specialist

Scistaff; Durban; On-site; ZAR 400 000 - 600 000; Full time

Job summary

A leading diagnostics manufacturer is looking for a Quality Assurance Specialist in Durban. The role involves supporting the quality management system with a focus on CAPA programs, conducting investigations, and performing risk assessments. Candidates should have a bachelor’s degree in Chemical Engineering or a related field and at least 3 years of experience in pharmaceutical manufacturing. Familiarity with Quality Management system standards is essential. Strong project management skills and experience with SAP-QM are also required.

Qualifications

• Minimum of 3 years’ experience in the pharmaceutical manufacturing environment.
• Working knowledge of pharmaceutical facilities, processes, equipment, and systems.
• Hands-on experience with Quality Management systems.

Responsibilities

• Support the company’s quality management system through CAPA programs.
• Conduct investigations and perform root cause analyses.
• Facilitate risk assessments for incidents and deviations.

Skills

Knowledge of Quality Management system regulations and standards

Project management skills

Experience with electronic systems (SAP-QM, Trackwise)

Robust knowledge of Microsoft Excel

Education

Bachelor’s degree in Chemical Engineering, Biology, Chemistry or related field

Tools

SAP-QM

Trackwise

Job description

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., ISO9001, ICH10, ISO13485; 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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