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,...
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Matric and National Diploma in Analytical Chemistry at NQF Level 6 as recognised by SAQA.
A higher qualification in analytical chemistry or quality management systems, post-graduate qualification in management would be advantageous. Valid driver’s license
EXPERIENCE:
Minimum of ten (10) years’ experience as an analytical chemist with 5 years’ experience in QC Laboratory Management.
Proven experience in the pharmaceutical industry (10 years), and a subject expert in QC testing, analytical method development and validation, stability testing and analytical method transfer.
Experience in the application of the Medicines and Related Substances Act and its regulations.
DUTIES:
Operational Management: Planning, managing and organising activities for third party laboratory services by considering a range of factors in the planning processes, communicating and documenting service level agreements and expectations, managing stakeholders, balancing quality of work with deadlines and budget, and reporting of these activities.
Strategic Management: Aligning third party laboratory services actions to organisational goals and targets by prioritising and monitoring actions, performing gap analyses, problem identification and solving, facilitating change through effective change management, capacitating through knowledge and creativity, and reporting on progress to goals and targets
Governance, Risk + Compliance: Responsible for development, implementation and maintenance of third party laboratory service related guidelines, standard operating procedures, work instructions and records in line with SAHPRA’s Quality Management System requirements, Public Finance Management Act requirements, World Health Organisation Global Benchmarking Tool’s indicators for Laboratory Testing and PIC/S Participating Authority requirements.
Financial Management: Responsible for compiling and managing the budget related to third party laboratory services, instituting risk management and adhering to procurement processes in order to ensure the achievement of organisational objectives, through preparation of budgets, monitoring of expenditure and revenue, understanding of financial accountability, understanding supply chain management, assessment management, PFMA and Treasury Regulation
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