Registration Pharmacist - Sandton
Salary Negotiable
Sandton,
Gauteng
more than 14 days ago
Reports to:
Regulatory Affairs Manager.
Location
Sandton
Salary
Market Related
Purpose of the Job
Pharmacist registered with South African Pharmacy Council, with at least 3 years’ experience in the registration of medicines for human use in South Africa, preferably including dermatological products. Production and/or quality assurance experience is beneficial. Fluent in English and good analytical, communication and presentation skills.
Apply for registration of new products with the South African Medicines Control Council (MCC) and to selective Health Authorities of other African countries
• Achieve expeditious approval to market by the Medicines Control Council of Company’s pending applications for registration.
• Maintain marketed products in compliance with regulatory requirements relating to the manufacture and sale of medicines.
• Maintain marketed products in compliance with registered specifications and achieve MCC approval of product changes.
• Approval of master documentation for the cosmetics that are manufactured locally and providing training on the Code of Practice relating to the Marketing of Medicines to all Company employees.
• Ensure that the company as well as persons employed providing a service deemed part of the scope of practice are appropriately registered with the Pharmacy Council, and that the annual registration of company’s medicinal products are maintained with the Medicines Control Council and take corrective measures for deficiencies identified in the Inspection Reports of the Pharmacy Council and Ensure controlled access to Regulatory Store room and sample retention cupboard.
• Assist the regulatory Affairs Manager in establishing policies and procedures for employees for the acts performed and services pertaining to the scope of practice of a Pharmacist provided by Company as a Manufacturing Pharmacy.
• Assist RAM in ensuring that manufacturers, quality control laboratories and warehouses and distributors of company’s products comply with cGMP (including cGLP, cGDP) and RSA legal requirements and ensuring on-going training of all company employees on the S.O. P’s in housekeeping and auditing in keeping within acceptable QA principles and GMP and GDP standards
Qualifications Education and Experience required
• Pharmacist Degree Essential.
• Extensive experience in regulatory affairs
• Registered the with South African Pharmacy Council.
• Production and/or quality assurance experience is beneficial.
• Please note that if you have not heard from us within 7 days, please consider your application unsuccessful
Regulatory Affairs Manager.
Location
Sandton
Salary
Market Related
Purpose of the Job
Pharmacist registered with South African Pharmacy Council, with at least 3 years’ experience in the registration of medicines for human use in South Africa, preferably including dermatological products. Production and/or quality assurance experience is beneficial. Fluent in English and good analytical, communication and presentation skills.
Apply for registration of new products with the South African Medicines Control Council (MCC) and to selective Health Authorities of other African countries
• Achieve expeditious approval to market by the Medicines Control Council of Company’s pending applications for registration.
• Maintain marketed products in compliance with regulatory requirements relating to the manufacture and sale of medicines.
• Maintain marketed products in compliance with registered specifications and achieve MCC approval of product changes.
• Approval of master documentation for the cosmetics that are manufactured locally and providing training on the Code of Practice relating to the Marketing of Medicines to all Company employees.
• Ensure that the company as well as persons employed providing a service deemed part of the scope of practice are appropriately registered with the Pharmacy Council, and that the annual registration of company’s medicinal products are maintained with the Medicines Control Council and take corrective measures for deficiencies identified in the Inspection Reports of the Pharmacy Council and Ensure controlled access to Regulatory Store room and sample retention cupboard.
• Assist the regulatory Affairs Manager in establishing policies and procedures for employees for the acts performed and services pertaining to the scope of practice of a Pharmacist provided by Company as a Manufacturing Pharmacy.
• Assist RAM in ensuring that manufacturers, quality control laboratories and warehouses and distributors of company’s products comply with cGMP (including cGLP, cGDP) and RSA legal requirements and ensuring on-going training of all company employees on the S.O. P’s in housekeeping and auditing in keeping within acceptable QA principles and GMP and GDP standards
Qualifications Education and Experience required
• Pharmacist Degree Essential.
• Extensive experience in regulatory affairs
• Registered the with South African Pharmacy Council.
• Production and/or quality assurance experience is beneficial.
• Please note that if you have not heard from us within 7 days, please consider your application unsuccessful