30.04.2024
Regulatory Affairs Pharmacist - Gauteng, Midrand
Taylored Appointments
South Africa, Midrand
Are you based in the United States? Select your country to see jobs specific to your location. Regulatory Affairs Pharmacist - Gauteng, Midrand To maintain a Quality Management System compliant with GMP/GDP/GWP requirements. To ensure compliance of the pharmaceutical requirement as stipulated by SAHPRA. Responsible to ensure that regulatory submissions and compliance are executed for all products in the company. Develop and communicate with our head office on the regulatory strategy and life cycle management of all products in the country. Represent the company within the local authority and other external partners. At local level, provide and ensure quality oversight of activities in a defined scope (manufacturing / I&D). Managing one employee. Must have Matric / Grade 12. Registered with the Pharmacy council. Must be computer literate (MS Word, Excel and PowerPoint -intermediate to advanced skills required) High accuracy and attention to detail skills. Strong work ethic. The following would enhance your position and will be an advantage: Previous Quality Assurance Management experience. Experience as a Responsible Pharmacist in a Manufacturing environment. Experience in compilation and submission of Act 101 (MCC) Dossiers, as well asAct 36 experience. Thorough understanding of GDP/GMP will be an advantage. Animal Health industry experience. Knowledge of regulatory submissions in Zimbabwe, Namibia&Zambia. Pharmaceutical Production knowledge. Experience in compilation and submission of Act 101 (MCC)Dossiers, as well as Act 36 experience. CTD submission experience will be an advantage. Main Accountabilities: Act as Responsible Pharmacist for the entity. Regulatory Strategy&intelligence. Responsible for the Regulatory Plan and the successful execution thereof. LOQ Answer, submission&interaction with authorities. Maintenance&product life cycle management. Knowledge and intelligence management. Right level of quality&strategy. Quality Management System&strategy. Community building and activation. Responsible for Pharmacovigilance. Audits&inspections. Desired Skills: Quality Assurance Management GDP/GMP Act 101 (MCC) Desired Work Experience: 2 to 5 years [other] Medical 5 to 10 years Pharmacist Desired Qualification Level&Accreditations: The number of jobs in each salary range for all: Alec Cameron&Associates Recruitment Solutions #J-18808-Ljbffr
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