Planning & organising skills To manage business compliance to relevant regulations & in accordance with the Pharmacy Act 53 of 1974 and the Medicines and Related Substances Act 101 of 1965. Manage, control and maintain the RSA’s certified Quality Management Systems in order to meet continual improvement of the established Quality Management System.. Key performance areas. Manage the QA/PQR budget and other resources in line with IHS objectives.. Manage and Control the SOP System, ensure that required SOP’s are initiated, implemented, reviewed and updated if required and reflect current business practices.. Review all SOP’s for regulatory compliance. Ensure reviews are conducted on a monthly basis. Manage the Non-conformance system by ensuring Non-conformances are initiated, reviewed and evaluated.. Monitor and ensure Pharmaceutical compliance to establish depth and management of quality team.. Manage the Internal Audit System, according to required standards (SAHPRA/GWP/ISO 9001:2015) and client requirements.. Compile respective reports, with suggested corrective actions and ensure that corrective actions are implemented within required timelines.. Manage the Client audit process.. Audit supplier/outsources services to ensure IHS requirements are achieved.. Compile and implement a cold chain validation program in accordance with regulatory and client requirements.. Review reasons for returns with Customer Services Manager.. Management of service delivery and Inventory on Schedule 6 items.. Induct new clients into QMS via project management, with respect to Pharmaceutical compliance.. Discuss Quality (MS) and Regulatory matters with staff, Responsible Branch General Managers & Responsible Pharmacists & make recommendations. Determine training needs to ensure continuous quality improvement.. Ensure technical agreements are in place with all client companies.. Responsible for regulatory conformance in Operations with regards to compliance to all approved SOP’s. Manage staff performance in terms of Quality Assessments on returned goods in accordance with approved criteria, product releases and sampling processes with respect to agreed benchmarks.. Ensure business process compliance to regulatory requirements. Review Change Control requests and ensure that regulatory compliance is observed. Desired Experience & Qualification. Experience in the Health/ Pharmaceutical Warehousing/ Distribution industry. Working knowledge of the Pharmacy and Medicines and Related Substances Control Acts. Knowledge of best practice Wholesale/Distribution Practices in South African. Self-development & Motivation. Decision-making, problem-solving, creativity. Analytical skills, attention to detail. Excellent communication skills in English. Ability to interact at a high level with relevant stakeholders. Ability to work in a team environment. Computer literacy – knowledge of SAP preferableAdd required skills / experience. Qualifications required. Minimum tertiary qualification (B.Pharm ,B.Sc Pharm). 8-10 years experience with at least 5 Years Senior Management experience as QA function Head and Reponsible Pharmacist.. Registration with the South African Pharmacy Council as a Pharmacist Imperial Health Sciences57 Sarel Baard Crescent, Centurion, 0157 Gauteng, South Africa
