Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients. A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees. Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development. For more information about Guerbet, please go to www.guerbet.com and follow Guerbet on Twitter @GuerbetGroup Job Purpose Working with cross-functional teams, you will have to be an excellent communicator and will be responsible for ensuring that all projects have the appropriate local quality, safety and regulatory input and guidance. Ensuring compliance with the legislative requirements as set out in the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974, as well as all applicable legislative requirements for the company’s product portfolio. You will have a solid knowledge GMP/GDP/GWP, Supply Chain, Compliance and Pharmacovigilance systems and have previously worked within the Pharmaceutical industry. Implementation and maintenance of an audit and quality assurance system. Maintenance and advancement of the regional SOP system. Principal responsibilities of the role Legal Ensure compliance with the legislative requirements as set out in the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974, as well as all applicable legislative requirements for the company’s product portfolio. Ensure compliance with statutory and regulatory requirements of SAHPRA, DoH, SA Pharmacy Council and related authorities in South Africa and other African countries where Guerbet products are sold. Ensure that the Radiation Control license for electro-medical devices (injectors) is annually renewed. Ensure the upkeep of the Medical Device license. Ensure that retention and licence fees are paid annually and that the licenses are in order. Ensure registration of RP and licensing of the company with Authorities. Ensure that a Designated Deputy (DD), who is a pharmacist, is in control of the facility should the RP be absent. Ensure that directors (when applicable) are au fait with the latest ethical rules of South African Pharmacy Council, the SA Guide to GMP and sign agreements to abide thereby. Ensure that all third-party contractors are legally approved and the applicable Technical Quality Agreements (TQA) are in place. Ensure compliance with the SA Marketing Code and comply with Global marketing policies. Ensure the implementation of ISO 13485:2016 requirements for a quality management system where the organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Understand and implement Medical Device guidelines in the local subsidiary. General Ensure good relations and communications with all members of the team and responding respectfully and in a timely fashion to internal and external customers. Interact influentially with all members of staff to maintain and develop a positive progressive Quality culture throughout the facility. Ensure that SEP (Single Exit Price) increases are submitted timely, and that all SEP projects are completed and submitted. Education & Background University degree as a Pharmacist Advanced degree in relevant subjects preferred.Equivalent relevant experience maybe considered. Expert knowledge of current GVP requirements Expert knowledge in GDP/GWP and GMP Knowledge in the field of Supply Chain. Experience: Minimum 5 years QA experience or relevant experience in pharmaceutical industry Sound experience in quality assurance and the conduct of audits In depth knowledge of the legislative requirements Demonstrable knowledge of Pharmacovigilance processes, across multiple Pharmacovigilance disciplines Knowledge of document management/quality systems Experience with SAHPRA and SAPC inspections preferred
