QA Specialist at National Bioproducts Institute

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 & 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.
• Ensure application of quality risk assessments in applicable areas in NBI’s business, i.e. assessment of quality risk related to customer complaints
• Evaluate the impact of risks to product SQE and ensure valid controls are proposed and implemented. Ensure appropriate CAPAs are identified for risk improvements.
• Promote and support the provision and application of science-based decision-making principles in support of assignment of impact rating score.
• 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 reactions
• Notifications for Corrective and preventative actions
• Follow up and report on notification status as required.
• Report on trends, incident types and classifications, open and closed notifications on a frequent basis.
• Report on the performance of these systems on a regular basis

Quality Assurance Systems and general department suppor

• Review relevant notifications and ensure completeness before closure.
• Prepare new and revise existing policies and standard operating procedures for applicable systems/processes to ensure compliance and appropriate use of tools.
• Assist in the conducting of training as required by the implemented training programme, new/revised policies and procedures, or as required by QA Manager.
• Present and discuss CAPA, impact assessments, investigations and trends during quality review meetings, as requested.
• Assist in the conducting of investigations and impact assessments as required by QA manager.
• Review and supervise the discard of retention samples in accordance with the relevant Quality and SHE procedures.
• Provision of support as required by QA Manager
• Promote and execute the quality vision throughout NBI
• Provide statistics and report on applicable systems as required.

Core Competencies

• Leading and Influencing Others
• Business Impact
• Managing Relationships
• Personal Leadership
• Hands on experience with Quality Management systems, especially on monitoring of CAPA, performing root cause analysis, investigations and risk assessments
• Strong analytical and problem solving skills
• Good technical writing skills
• Excellent attention to detail
• Ability to work independently with minimal supervision
• Good team work & interpersonal skills
• Ability to communicate with teams and encourage them to think in new and more process oriented ways
• Ability to work with individuals across all levels of the company, including management
• Robust knowledge of Microsoft Excel and/or other trending tools
• Experience with electronic systems such as SAP-QM and Trackwise is preferred
• Knowledge of Quality Management system regulations and standards (e.g. ISO9001, ICH10, ISO13485) is preferred
• Project management skills are preferred
• Confident
• Self-motivated