Quality Assurance Manager (post level 8) (Job ID: 5582) at University of the Free State

Duties and responsibilities:

Quality Assurance Management:

• Responsible for the maintenance and improvement of the management system and ensure all staff comply with the requirements of ISO/IEC 17025:2017, the World Health Organisation (WHO) and Good Manufacturer Practice (GMP) for the South African Health Products Regulatory Authority (SAHPRA).
• Provide guidance to the Management of the South African National Control Laboratory for Biological Products (SANCLBP) on policies and planning in respect of the quality management system.
• Manage the competency profiles and training of all staff according to ISO/IEC 17025:2017and GMP requirements including management of training plans and training records. 
• Provide guidance to management and assuring compliance with all aspects of documentation and data control and security.
• Manage and perform internal technical and management audits of the entire system. 
• Manage and coordinate external audits by WHO, SAHPRA, and SANAS (South African National Accreditation system), to ensure compliance with requirements. 
• Make recommendations to SANCLBP management.
• Evaluate external suppliers to the SANCLBP to ensure compliance with ISO 9001, ISO/IEC 17025:2017, and GMP requirements. 
• Perform audits of suppliers when necessary.
• Plan and coordinate the annual Management review meeting and generate the minutes/report, action plans, improvements, risks, and new objectives.
• Review and update the SANCLBP Quality Manual (QM) in compliance with 1SO/IEC 17025:2017 and the Site Master file in compliance with SAHPRA requirements. 
• Compile SAHPRA documentation as required.
• Review, update and distribute all Quality Management System documentation to reflect laboratory procedures and manage the archiving system of all records and documentation.
• Manage, track, and monitor the clearance of non-conformances within the laboratory. 
• Analyse and perform trend analysis thereof and report to the weekly laboratory.
• Manage, track, and monitor the planned deviations, changes implemented, and improvements within the laboratory.
• Perform risk assessments on the entire system during internal audits, and non-conformances, after updating quality management documentation, approving new suppliers, planned deviations, and on changes that are implemented.
• Manage impartiality agreements and disclosures of SANCLBP staff.
• Manage confidentiality agreements of external individuals that have access to laboratory activities or data.
• Manage the yearly customer satisfaction survey of clients. Analyse the results, compile the report, and follow up on unsatisfactory outcomes.
• Handle official complaints from outside against the SANCLBP and liaise with the complainants.
• Provide technical input in the content and manage the documentation system for validation plan reports and validation reports.
• Manage the documentation system for the External quality control activities in the laboratory.
• Ensure that the personnel profiles are current by sending out reminders of CV's and job descriptions to be reviewed and updated.
• Manage department POPIA compliance in line with the requirements of the UFS POPIA policy.

Health and Safety:

• Oversee and provide input to the health and safety officer (H&S officer) to ensure a safe working environment and compliance with the Occupational Health and Safety Act.
• Oversee and monitor all health and safety (H&S) activities according to the laboratory's policy and procedures including, H&S meetings, H&S training, safety inspections, fire drills, biological and chemical waste, pest control, and maintenance of safety equipment and first aid accessories.

Training and Development:

• Train new staff on the quality management system.
• Identify the needs obtained from conducting internal audits and from non-conformances for on-the-job training and continuing education of staff on quality issues with regards to 1SO/IEC 17025:2017, GMP, and WHO requirements.
• Identify the needs for on-the-job training and continuing education of allocated staff.
• People Management:
• Train, supervise and manage performance of the QA /H&S officer.
• Perform PM assessment yearly and have yearly discussion with allocated staff.
• Manage and assist with performance management system documents.

Inherent Job requirements:

• A relevant bachelor’s degree or an advanced diploma/BTech degree/postgraduate certificate on NQF Level 7 OR a relevant three-year national diploma on NQF Level 6 in a biological science-related field.
• Certification for training related to ISO/IEC 17025:2017 or 1S0/IEC 15189:2022 requirements, including internal auditing, risk identification and assessment, root cause analysis and corrective action.
• Minimum of three (3) years’ Quality Assurance Management and Laboratory Management experience with a proven track record of managing external audits for SANAS ISO/IEC 17025:2017 or ISO/IEC 15189:2022 inspections.

Recommendations:

• Experience in quality assurance within a GMP-regulated environment.
• Experience in biophysical chemistry and/or bioanalytical test methods.
• Knowledge of health and safety regulations as defined in the Occupational Health and Safety Act.
• Knowledge of the relevant guidance documents related to the testing and control and regulation of biological medicines and vaccines, these include documents published by the SAHPRA, WHO, and the EDOM.