QA Specialist

**Job Advert Summary**:
Guided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBI’s vision is to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products.

National Bioproducts Institute NPC has a vacancy for the role of QA Specialist. The successful incumbent will be required to support NBI 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 NBI’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 NBI’s quality management system, cGMP and regulatory requirements.

**Minimum Requirements**:

- Bachelor’s Degree in Chemical engineering, Biological, Chemistry, Pharmaceutical Sciences or related field
- A minimum of 3 years experience in the pharmaceutical manufacturing environment, with working knowledge of pharmaceutical facilities, processes, equipment, laboratories and systems is required.
- Experience with HAZOP, FMEA in other manufacturing industries may also be considered.
- Experience in biotechnology or biopharmaceutical manufacturing is preferred.

**Duties and Responsibilities**:
**Maintain formal CAPA programme, effectiveness monitoring of CAPAs implemented**
- Support and continuously improve a formal CAPA program, meeting the requirements of the South African Health Products Regulatory Authority (SAHPRA), PICs guidelines and international regulatory agencies such as ICH and the relevant ISO standards.
- Implementation of corrective and preventive actions and effectiveness monitoring based on sound scientific principles and business and compliance risk mitigation.
- Support the rollout of any new CAPA solutions (tools, techniques, matrices and/or process enhancements).
- Monitor and track compliance to the overall CAPA program, and escalation as appropriate
- Assist responsible staff in timely completion of CAPA actions and provide project management support to CAPA teams as required.
- Ensure CAPA tracking and trending is robust and accurate, data is analysed, adverse trends are identified, and CAPA effectiveness is routinely reviewed in an effort to successfully address adverse trends.
- Prepare written CAPA investigation reports and support documents.

**Conduct investigations and root cause analysis**
- Conduct independent and structured investigations for major incidents, and consult with SME where required.
- Conduct root cause analyses for major/repeated incidents based on sound scientific principles and business and compliance risk mitigation.
- Ensure investigations are well documented by compiling related reports in a timely and organized manner.
- Review investigation reports and critically assess to ensure investigation is robust and well documented.
- Organise and facilitate meetings for root cause analyses of major incidents and/or trends in deviations/OOS identified. Prepare minutes and report on such meetings.
- Organise and facilitate meetings with relevant stakeholders for materials including final products pending disposition decisions. Prepare minutes and report on such meetings.
- Assemble and work in multi-disciplinary teams to resolve complex problems which require experience with quality systems and biopharmaceutical manufacturing.
- Develop and use strong understanding of all critical manufacturing process parameters, combined with cGMP quality knowledge to identify and drive systemic quality improvements.
- Translation and incorporation of training resulting from investigations, notifications, customer complaints or batch documentation review into training programme

**Risk assessments and impact evaluation**
- Facilitate risk assessments with SME and ensure integration of risk assessments with the Change Control and the notification systems by ensuring effective execution of quality risk assessments related to any changes and incidents/OOS/deviations.
- Evaluate the impact of risks to product SQE and ensure valid controls are proposed and implemented. Ensure appropriate CAPAs are identified for risk improvements.
- Evaluation of the effectiveness of established controls identified
- Implement risk management tools and train others on appropriate use of these to execute risk assessments.
- Maintain a register for the tracking of risk assessments conducted.

**Support the applicable notification systems**
- SAP QM: Responsible for workflows for the following systems in SAP QA through ensuring notifications are created and put into process
- Notifications for internal problems
- Notifications for customer complaints
- Notifications for adverse drug re