Quality Assurance Specialist

SciStaff CC; Durban; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading pharmaceutical company in Durban is seeking a Quality Assurance Specialist to manage a formal CAPA program and ensure compliance with regulatory requirements. Candidates should possess a Bachelor's degree in Chemical Engineering or related fields and have at least 3 years of experience in pharmaceutical manufacturing. Knowledge of Quality Management Systems and tools like SAP-QM is essential. The role involves investigating incidents, performing root cause analysis, and conducting risk assessments to uphold quality standards.

Qualifications

• At least 3 years experience in the pharmaceutical manufacturing environment.
• Knowledge of ISO9001, ICH10, and ISO13485 regulations.
• Experience in biotechnology or biopharmaceutical manufacturing is preferred.

Responsibilities

• Support the company’s mission through formal CAPA program implementation.
• Investigate incidents and perform root cause analyses.
• Monitor effectiveness of corrective actions and risk assessments.

Skills

Quality Management System knowledge

Root Cause Analysis

Project Management

Risk Assessment

Microsoft Excel

Education

Bachelor's Degree in Chemical Engineering or related field

Tools

SAP-QM

Trackwise

Job description

Responsibilities

The successful incumbent will be required to support the companys 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 companys 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 companys 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.

Qualifications

Key Requirements: Bachelors 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