Job Description

KINDLY TAKE NOTE: Applications may only be submitted online through the official UFS vacancy website: . Applications submitted through any other platform will not be considered.

Duties and responsibilities:
Quality Assurance Management:
o 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).
o 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.
o 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.
o Provide guidance to management and assuring compliance with all aspects of documentation and data control and security.
o Manage and perform internal technical and management audits of the entire system.
o Manage and coordinate external audits by WHO, SAHPRA, and SANAS (South African National Accreditation system), to ensure compliance with requirements.
o Make recommendations to SANCLBP management.
o Evaluate external suppliers to the SANCLBP to ensure compliance with ISO 9001, ISO/IEC 17025:2017, and GMP requirements.
o Perform audits of suppliers when necessary.
o Plan and coordinate the annual Management review meeting and generate the minutes/report, action plans, improvements, risks, and new objectives.
o 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.
o Compile SAHPRA documentation as required.
o Review, update and distribute all Quality Management System documentation to reflect laboratory procedures and manage the archiving system of all records and documentation.
o Manage, track, and monitor the clearance of non-conformances within the laboratory.
o Analyse and perform trend analysis thereof and report to the weekly laboratory.
o Manage, track, and monitor the planned deviations, changes implemented, and improvements within the laboratory.
o 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.
o Manage impartiality agreements and disclosures of SANCLBP staff.
o Manage confidentiality agreements of external individuals that have access to laboratory activities or data.
o Manage the yearly customer satisfaction survey of clients. Analyse the results, compile the report, and follow up on unsatisfactory outcomes.
o Handle official complaints from outside against the SANCLBP and liaise with the complainants.
o Provide technical input in the content and manage the documentation system for validation plan reports and validation reports.
o Manage the documentation system for the External quality control activities in the laboratory.
o Ensure that the personnel profiles are current by sending out reminders of CV's and job descriptions to be reviewed and updated.
o Manage department POPIA compliance in line with the requirements of the UFS POPIA policy.
Health and Safety
o 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.
o 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
o Train new staff on the quality management system.
o 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.
o Identify the needs for on-the-job training and continuing education of allocated staff.
People Management
o Train, supervise and manage performance of the QA /H&S officer.
o Perform PM assessment yearly and have yearly discussion with allocated staff.
o Manage and assist with performance management system documents.

Inherent Job requirements:
A relevant bachelors 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.

Key Competencies required:
Results orientated:
o The ability to stick with tasks, not give up, and overcome obstacles in completing ones task.
o The ability to be reliable, responsible, dependable and to fulfil obligations.
Strategic thinking:
o The ability to focus on details, work towards perfection, and approach work in a neat and organized manner.
o The ability to plan work and to follow plans.
Business acumen:
o The ability to adhere to rules and strictly follow work regulations.
o Proficient in using MS Office.
o Excellent written and verbal communication skills.
Leading:
o The ability to lead, take charge of situations, and offer opinions and directions to others.
o The ability to be cooperative with others, display good-natured attitude, and encourage people to work together.
Building coalitions:
o The ability to be self-assured and at ease with people in all types of social situations.
o The ability to interact with others and establish personal connections with people.

Required Documents

Please ensure all relevant documentation is attached to your application. INCOMPLETE APPLICATIONS WILL NOT BE CONSIDERED.
*Certified copies must not be older than 6 months

A detailed curriculum vitae and cover letter.
Certified copies (not older than 6 months) of all academic records.
Certified copies (not older than 6 months) of qualifications (please provide the SAQA accreditation in the case of foreign qualifications).
A certified copy (not older than 6 months) of your identity document (ID).
Proof of registration with a Professional Body (if applicable).
A copy of your drivers license (if applicable).
A service record of your current employer / last employer (only applicable to external applicants).

Assumption of duties:
01 October 2023.

Closing date:
26 August 2023.

Salary:
The annual remuneration package, including benefits, is R607 945.39 R761 948.08 per annum depending on the budget available for the position, relevant work experience and qualifications.

Fringe benefits:
(Subject to specific conditions): pension scheme, medical aid scheme, group life insurance, housing allowance, leave and sick leave, service bonus and study benefits.

Enquiries:
For enquiries, please feel free to contact me at 051 401 9810 or email at or . Additionally, kindly contact 051 401 2979 / 9813 / 9814/ 9848 for assistance.

General:
The UFS is a designated employer and is committed to the pursuit of excellence, diversity, and redress in achieving its equity targets in accordance with the Employment Equity Plan of the University and its Employment Equity goals and targets. Preference will be given to candidates from the under-represented designated groups including candidates with disabilities. Our Employment Equity Policy is available at :

The University processes personal information in line with its obligations under the Protection of Personal Information Act (POPIA) and any personal information provided to the University will be treated as confidential and processed in accordance with the rights provided to data subjects under POPIA.

The University reserves the right not to fill the post. The UFS will only consider applications of candidates who meet all the inherent requirements of the position. Applications that are incomplete will not be considered. Communication will be limited to shortlisted candidates only. Should you not be contacted within six weeks of the closing date for applications, you may assume that your application was unsuccessful.

The UFS will only consider applications of candidates who meet all the inherent requirements of the position.

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