Responsible 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 Qualification

Bachelor of Pharmacy Degree

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 skills

Attributes:

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.

RESPONSIBLE PHARMACIST:

 Contemplated in regulation 25 (3) of the Pharmacy Act and the relevant sections of the Medicines Act shall:

 Ensure that he or she in fact continuously supervises the pharma division.

 Have appropriate qualifications and experience in the services being rendered by the company.

 Ensure that persons being employed by the company and who provide services forming part 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 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 unauthorised persons do not obtain access to medicines or scheduled substances or the pharmacy premises outside of normal trading hours.

 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.

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 Assurance Pharmacist.

 Compile a letter of delegation of authority in his/her absence.

 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.

 Be part of 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 pharmacy

 Ensure that no person is appointed to perform any act falling outside the scope of practice of the category 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 such pharmacy business and furnish Pharmacy Council with a copy thereof.

 Not introduce or carry out any instruction or order of management with regard to the pharmacy business 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 AFFAIRS PHARMACIST

Regulatory Activities

Delivery of annual product submission plan

 Compiling/overseeing submission of dossiers according to annual product submission plan to SAHPRA and regional Medicines Regulatory Authorities within SADC.

 Due diligence on prospective dossiers from India as well as other third parties.

Delivery of Future Registrations

 Continous 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.

Life Cycle Management

 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.

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 Review

 Review for compliance with the registered dossier and final approval before print (APLSA and third parties).

Marketing Material

 Provide regulatory support during concept design of all new marketing material.

 Ensure compliance of all marketing material with the Marketing Code Authority and legislation.

QUALITY ASSURANCE/COMPLIANCE

 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.

 Vendor inspection audits when required.

 Overseeing the handling of technical product complaints and queries in accordance with the guidelines and requirements.

 Providing feedback to the business regarding any quality issues in the Quality Management Review.

TRAINING AND SUPPORT

 Providing 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 when required.

THIRD PARTY

 Liaising with India on all regulatory and quality assurance activities.

 Co-ordinating GMP/GCP inspections of parent company’s manufacturing facilities with inspectors from the various Regulatory Authorities.

 Controlling correspondence with other pharmaceutical companies and pharmaceutical consultants 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 above.

PHARMACOVIGILANCE

 Collection of adverse drug reactions and reporting it to the global Pharmacovigilance department.

 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 global Pharmacovigilance informed of significant developments relating to Pharmacovigilance.

 Ensuring “Dear Healthcare Professional” letters are sent out in the event of urgent safety updates.

 Overseeing that package inserts are updated to reflect the latest updated safety information.

LOCAL MANUFACTURING TECHINICAL RESPONSIBILITIES

 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.

 To provide technical support to the CMO regarding any queries or concerns related to any of the company’s products.