- Published on
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) - MANAGER: QUALITY MANAGEMENT SYSTEMS
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
MANAGER: QUALITY MANAGEMENT SYSTEMS
Ref No.: SAHPRA 017/2020
CENTRE: Pretoria
REQUIREMENTS: • Relevant 4-year degree health sciences and related qualifications (e.g. BSC, natural sciences. • A post graduate qualification in quality management systems is required. • Minimum 3 years’ relevant management experience. • The post holder must have at least 7 years’ relevant experience in quality management field. • Quality Management System Auditing experience and managing audit programmes. •Extensive knowledge and understanding of quality systems, quality practices and regulatory processes. •Demonstrated ability to develop, implement and assess quality management system at organisation or business unit level.
COMPETENCIES/SKILLS: •Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. •Preparation and management of strategic plans, business plans and budgeting. •Performance measurement skills.
• Self-motivated and able to work independently. •Ability to manage a variety of cross-functional team members. •Competent in problem solving and team building. •Information evaluation. • Decision making. • Objectivity. •Resilience. • Communication skills (verbal, written, negotiation, conflict management, presentation). • Interpersonal skills. • Assertiveness. • Ethical behaviour. •Customer service •Planning and Organising skills. • Team Management
DUTIES: Business Support and Advisory: • Contribute to the creation and implementation of best practice capacity planning vision, strategy, policies, processes and procedures to aid and improve operational performance. • Contribute to new business initiatives and projects and review and communicate the impact on Quality Management Systems (QMS). • Report on achievement of targets and identify any actions required. • Train and manage SAHPRA managers to ensure they have the skills required by SAHPRA and can achieve their QMS objectives. • Identity business improvement opportunities within the organisation. • Advise management on compliance of SAHPRA staff to established procedures, implementation of quality audits and advise on appropriate corrective action to be taken to ensure Quality Policy and objectives, SAHPRA mission and vision are met. •Supports the management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities and process and procedure improvements to optimise results and improve quality of delivery. QMS Governance and Compliance: • Develops the Quality Management Systems strategy and the management arrangements for key milestones, demonstrating solid progress against plan. • Develop and revise quality policy, quality objective and quality manual for SAHPRA processes and procedures. • Sets and oversees development, implementation of the policy and procedures with regard to quality assurance and relevant certification, in line with regulatory benchmarks. • Ensure compliance with current legislation, regulations and standards. •Introduce new systems and procedures where necessary. QMS Risk Management: • Facilitate Quality Audit Team and prepare time schedule for internal Quality Audits. • Prepare an internal quality audits plan taking into account technical factors. • Conduct regular internal quality audits of SAHPRA processes to verify whether they are conducted according to established procedures and prepare report. • Ensure corrective actions are undertaken to address non conformities found. • Monitor implementation of recommendations of internal quality audit reports and submit reports to the Management for review.
DUTIES: Business Support and Advisory: • Contribute to the creation and implementation of best practice capacity planning vision, strategy, policies, processes and procedures to aid and improve operational performance. • Contribute to new business initiatives and projects and review and communicate the impact on Quality Management Systems (QMS). • Report on achievement of targets and identify any actions required. • Train and manage SAHPRA managers to ensure they have the skills required by SAHPRA and can achieve their QMS objectives. • Identity business improvement opportunities within the organisation. • Advise management on compliance of SAHPRA staff to established procedures, implementation of quality audits and advise on appropriate corrective action to be taken to ensure Quality Policy and objectives, SAHPRA mission and vision are met. •Supports the management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities and process and procedure improvements to optimise results and improve quality of delivery. QMS Governance and Compliance: • Develops the Quality Management Systems strategy and the management arrangements for key milestones, demonstrating solid progress against plan. • Develop and revise quality policy, quality objective and quality manual for SAHPRA processes and procedures. • Sets and oversees development, implementation of the policy and procedures with regard to quality assurance and relevant certification, in line with regulatory benchmarks. • Ensure compliance with current legislation, regulations and standards. •Introduce new systems and procedures where necessary. QMS Risk Management: • Facilitate Quality Audit Team and prepare time schedule for internal Quality Audits. • Prepare an internal quality audits plan taking into account technical factors. • Conduct regular internal quality audits of SAHPRA processes to verify whether they are conducted according to established procedures and prepare report. • Ensure corrective actions are undertaken to address non conformities found. • Monitor implementation of recommendations of internal quality audit reports and submit reports to the Management for review.
INSTRUCTIONS TO APPLICANTS: All applications must:
Be made on Z83 forms (obtainable http://www.dpsa.gov.za/dpsa2g/documents/forms/employ.pdf or from any Government department).
Be completed in full, clearly reflect the name of the position, name and date of the publication (candidates must use the post reference numbers), be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s. Applications without the afore-mentioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
A separate application form must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated.
DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Tel: +27 71 605 1508.
Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 May 2020 at 16H00