RESPONSIBLE PHARMACIST & REGULATORY AFFAIRS/QUALITY ASSURANCE PHARMACISTDEPARTMENTRegulatory DepartmentREPORTING LINE MANAGER Chief Executive OfficerOverallobjectiveofJobFunctionResponsible Pharmacist: The Responsible Pharmacist is a natural person who is a pharmacist and who shall be 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.Regulatory Affairs: To ensure company compliance with regulatory requirements relating to the submission and maintenance of medicines in South Africa and other designated territories.Quality Assurance: To 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.Minimum QualificationBachelor of Pharmacy DegreeBasic Competencies and minimum experience(Knowledge, Skills & Attributes)Knowledge:Computer literacy.Must have a thorough understanding of the laws and regulations governing registration of medicines in the applicable territories.Skills:Organisational and managerial skills; problem solving; analytical skills; service orientation; decision making skills; interpersonal skills; report writing skillsAttributes:Attention to detail; initiative; confidentiality; customer focused; logical thinking; information seeking; sense of urgency.Experience:Previous working experience in Production and Quality Assurance is advantageous.5 years experience in a Regulatory Affairs department.Key Performance AreasRESPONSIBLEPHARMACIST:Contemplated in regulation 25 (3) of the Pharmacy Act and the relevant sections of theMedicines Act shall:Ensure that he or she in fact continuously supervises.Have appropriate qualifications and experience in the services being rendered.Ensure that persons being employed and who provide services formingpart of the scope of pharmacy practice of a pharmacist are appropriately registered with the Pharmacy Council.Notify the Pharmacy Council immediately upon receiving knowledge that his/her services asresponsible pharmacist have been or will be terminated.Take corrective measures in respect of deficiencies with regard to inspection reports of thePharmacy Council or in terms of the Medicines Act, and in addition to the general responsibilities also.Ensure that un-authorised persons do not obtain access to medicines or scheduled substancesor the pharmacy premises outside of normal trading hours.Establish policies and procedures for the employees of the pharmacy with regard to the actsperformed and services provided in the pharmacy.Ensure the safe and effective storage and keeping of medicine or scheduled substance in thepharmacy under his or her direct personal supervision.Have the overall responsibility for release of the finished products to the market.Ensure correct and effective record keeping of the purchase, sale, possession, storage,safekeeping and return of medicines or scheduled substances.Initiate and co-ordinate all recall activities which should involve the Quality AssurancePharmacist.Compile a letter of delegation of authority in his/her absence.Control the manufacturing or distribution of medicines, scheduled substances or medical devicesin terms of the provisions of the Medicines Act, 1965.Ensure that there is compliance with Good Pharmacy Practice as published by the PharmacyCouncil.Be part if the decision-making process affecting the pharmacy business.Ensure that the pharmacy owner complies with all the conditions of -- ownership of such pharmacy business- registration of the pharmacyEnsure that no person is appointed to perform any act falling outside the scope of practice of thecategory in which such person is registered or which he/she is not authorised to perform in terms of the Pharmacy Act, 1974 (Act 53 of 1974).Report in writing any non-compliance with the Pharmacy Act to the management of suchpharmacy business and furnish Pharmacy Council with a copy thereof.Not introduce or carry out any instruction or order of management with regard to the pharmacybusiness of the pharmacy owner which could amount to a contravention of legislation applicable to such pharmacy business and be responsible to the Medicines Control Council for compliance with the provisions of the Medicines and Related Substances Act, 1965 (Act 10 of 1965) relating to the sale control of the manufacturing and distribution of medicines, scheduled substance or medical devices.REGULATORY ACTIVITIESDelivery of annual product submisson planCompiling/overseeing submission of dossiers according to annual product submission plan toSAHPRA and regional Medicines Regulatory Authorities within SADC.Due diligence on prospective dossiers from India as well as other third parties.Delivery of Future RegistrationsContinous liaison with SAHPRA to ensure new product registrations are received on time tosatisfy the requirment of the business.Compile/oversee that recommendations are responded to timeously.Life Cycle ManagementTo ensure that necessary updates are made to the Registration Dossier according to latestrequirements of the MRA, including conversation of dossiers to the ZA-CTD.To ensure timely approvals of post registration amendments to avoid out of stock.To ensure that the MRA is informed of changes to the registration dossier.Printed Packaging Material ReviewReview for compliance with the registered dossier and final approval before print (APLSA andthird parties).MarketingMaterialProvide regulatory support during concept design of all new marketing material.Ensure compliance of all marketing material with the Marketing Code Authority and legislation.QUALITYASSURANCE/COMPLIANCEOverseeing compliance to batch documentation review, annual product reviews, trend analysisand 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.Vendor inspection audits when required.Overseeing the handling of technical product complaints and queries in accordance with theguidelines and requirements.Providing feedback ti the business regarding any quality issues in the Quality ManagementReview.TRAINING AND SUPPORTProviding training and support to Regulatory Affairs Pharmacist and Assistants.Training and implementation on new SAHPRA guidelines.Training to sales and office personnel on Pharmacovigilance and other relevant subjects whenrequired.THIRDPARTYLiaising with India on all regulatory and quality assurance activities.Co-ordinating GMP/GCP inspections of parent companys manufacturing facilities withinspectors from the various Regulatory Authorities.Controlling correspondence with other pharmaceutical companies and pharmaceuticalconsultants with regards to regulatory activities.Vendor inspection audits of distributors and laboratories.Finalising agreements with third party contract laboratories.Customer relationship management with all third parties mentioned abovePHARMACOVIGILANCECollection of adverse drug reactions and reporting it to the global Pharmacovigilancedepartment.Providing Pharmacovigilance training and documenting these training activities.Provide global Pharmacovigilance with sales data and regulatory information on request.Keep abreast with applicable South African laws, rules and regulations and keep globalPharmacovigilance informed of significant developments relating to Pharmacovigilance.Ensuring "Dear Healthcare Professional" letters are sent out in the event of urgent safetyupdates.Overseeing that package inserts are updated to reflect the latest updated safety information.LOCAL MANUFACTURING TECHINICAL RESPONSIBILITIESEnsure that CMO remains GMP compliant and complies with all local legislation andrequirements as oer the product dossiers.Ensure that all batch documentation is reviewed and releases are done appropriately to ensurethat safe and quality products are released to the public.To provide technical support to the CMO regarding any queries or concerns related to any ofThe companys products.
