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RESPONSIBLE PHARMACIST AND REGULATORY AFFAIRS - 364649
RESPONSIBLE PHARMACIST AND REGULATORY AFFAIRS
Healthcare/ Pharmacies / Hospitals / Medical / Emergency Services
Wage / Salary:
R - Market Related - P/M (Per Month)
Responsible Pharmacist and Regulatory Affairs/QA Pharmacist
Responsible to the council for complying with all the provisions of the Pharmacy Act No. 53 of 1974 and other legislation applicable to services which specially pertain to the scope of practice of a pharmacist, and the legislation applicable to the pharmacy which is under his or her personal supervision.
Ensure company compliance with regulatory requirements relating to the submission and maintenance of medicines in South Africa and other designated territories.
Ensure company compliance with sound Quality Assurance principles, good manufacturing practice and regulatory requirements relating to the warehousing/distribution of medicines in South Africa, including the product complaint reporting process, product release, internal and external audits and GMP training.
Qualifications and Experience:
Bachelor of Pharmacy Degree
Previous working experience in Production and Quality Assurance is advantageous.
5 years’ experience in a Regulatory Affairs department.
Must have a thorough understanding of the laws and regulations governing registration of medicines in the applicable territories.
Control the manufacturing or distribution of medicines, scheduled substances or medical devices in terms of the provisions of the Medicines Act, 1965.
Ensure that there is compliance with Good Pharmacy Practice as published by the Pharmacy Council.
Notify the Pharmacy Council immediately upon receiving knowledge that his/her services as responsible pharmacist have been or will be terminated.
Take corrective measures in respect of deficiencies with regard to inspection reports of the Pharmacy Council or in terms of the Medicines Act, and in addition to the general responsibilities also.
Ensure that unauthorized persons do not obtain access to medicines or scheduled substances or the pharmacy premises outside of normal trading hours.
Compiling/overseeing submission of dossiers according to annual product submission plan to SAHPRA and regional Medicines Regulatory Authorities within SADC.
Ensure that CMO remains GMP compliant and complies with all local legislation and requirements as per the product dossiers.
Ensure that all batch documentation is reviewed and releases are done appropriately to ensure that safe and quality products are released to the public.
Continuous liaison with SAHPRA to ensure new product registrations are received on time to satisfy the requirement of the business.
Compile/oversee that recommendations are responded to timeously.
Review for compliance with the registered dossier and final approval before print (APLSA and third parties).
Overseeing compliance to batch documentation review, annual product reviews, trend analysis and overall quality risk management.
Ensuring adherence to SAHPRA and GMP guidelines by all relevant personnel.
SOP review and approval, creation of new SOPs as and when required.
Ensure compliance of all marketing material with the Marketing Code Authority and legislation.
To ensure that necessary updates are made to the Registration Dossier according to latest requirements of the MRA, including conversation of dossiers to the ZA-CTD.
Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances.
Initiate and coordinate all recall activities which should involve the Quality Assurance Pharmacist.
Compile a letter of delegation of authority in his/her absence.
Establish policies and procedures for the employees of the pharmacy with regard to the acts performed and services provided in the pharmacy.
Ensure the safe and effective storage and keeping of medicine or scheduled substance in the pharmacy under his or her direct personal supervision.
Have the overall responsibility for release of the finished products to the market.