An exciting career opportunity exists at Kawari for a Responsible Pharmacist, this position is based in Midrand. Kawari Wholesalers, a pharmaceutical wholesaler and distributor requires a dedicated Responsible Pharmacist. This individual must have extensive knowledge of the different regulatory bodies that govern the pharmaceutical industry and applicable laws, regulations and legislation. This individual needs to ensure Kawari remains compliant with all legal and regulatory requirements.
Primary Purpose of the Job
“Responsible Pharmacist” means a natural person who is a pharmacist and who shall be responsible to the Pharmacy Council for complying with all the provisions of the Pharmacy Act, Act 53 of 1974 and to the South African Health Products Regulatory Authority (SAHPRA) for complying with the Medicines and Related Substance Act 101 of 1965 and other legislation applicable to services which specially pertain to the scope of practice of a pharmacist, and the legislation applicable to the pharmacy under which his or her personal supervision and who is registered as such in terms of the Act.
Primary Responsibilities
GOOD WHOLESALING AND DISTRIBUTION PRACTICES
- Ensure that he or she supervises the pharmacy in which he or she has been appointed.
- Have appropriate qualifications and experience in the services being rendered by such pharmacy.
- Ensure that persons employed in such pharmacy and who provide services forming part of the scope of practice of a pharmacist are appropriately registered with the council.
- Notify 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 council or in terms of the Medicines Control Act.
In addition to the general responsibilities:
- Ensure that unauthorized persons do not obtain access to medicines or scheduled substances of the pharmacy premises at any time.
- Establish policies and procedures for the employees of the pharmacy with regards to the acts performed and services provided by the pharmacy.
- Ensure safe and effective storage and keeping of medicine or scheduled substances in the pharmacy under his/her direct personal supervision.
- Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances.
LEGAL
- To ensure registration of RP and company with the SAPC, license with DOH & MCC wholesale license (Section 22C (1) (b) of Act 101 of 1965).
- To ensure name of the RP is prominently displayed over the entrance.
- To ensure that the pharmaceutical facility is conducted under the continuous supervision of the responsible pharmacist (legal requirement).
- To ensure the deputy pharmacist is in control of the facility should the RP be absent.
- To ensure that all directors are au fait with the latest ethical rules and agree to abide thereby.
- To ensure that contracts exist between the license holder and 3rd party contractors stipulating where all responsibilities lie.
- To approve and sign off all advertising material and to ensure that the material is legal.
- To maintain SMF, update and submit to MCC if changes occurred.
- To maintain all SOPs and add new SOPs as needed.
- To handle and approve all changes via change control.
- To ensure that all required textbooks are on hand (SAPC requirement).
- Ensuring that quality, efficiency, and safety of pharmaceutical products are maintained through the distribution chain.
COMPLAINTS
- To ensure that all product complaints are investigated and identified as to the nature of the problem and are given the necessary attention.
- To ensure that product complaints involving “adverse drug reactions” are reacted upon and followed up without delay.
- CAPA’s (Corrective and Preventive Actions) completed as per applicable SOP.
RECALL
- To be able to handle a medicine recall according to correct procedure and to assist product license holders with their product recalls.
- To ensure that all batches of medicine distributed are batch traceable in the event of a recall and that all invoices carry batch numbers.
- To ensure that SAHPRA is immediately informed of any possible withdrawal of unwanted medicine or counterfeit medicine in/from the market.
RETURNED/REJECTED/QUARANTINED GOODS
- To ensure that goods returned are handled in a procedurally correct manner, reason for returns determined and any further actions followed through and recorded.
- To be responsible for final decision, after evaluation to return or destroy any returned/reworked (reviewed before return to stock)/rejected goods.
- Maintain and handle all quarantined goods i.e., returns, rejects, etc.
- To ensure that the disposal or destruction of all schedule 5 and schedule 6 medicines are conducted according to SAHPRA guidelines.
GOOD WAREHOUSE AND DISTRIBUTION PRACTICE
- To ensure that all employees are conversant with the system laid down for using and following the standard operating procedures.
- To ensure that identified personnel and staff roles and responsibilities are in place.
- To ensure that the GWP training and if necessary outside training is conducted, recorded and maintained, continuous training is conducted.
- Quality Management System (QMS) and Quality Awareness Program is implemented and maintained.
- To ensure that all general good housekeeping practices are maintained with regards to:
Self-inspection, Temperature control and monitoring, Pest control, Fire extinguishers, Cleaning of warehouse, bathrooms and passages with appropriate cleaning records, Correct storage conditions during storage and transportation, Handling of returned goods, rejected goods, etc., Handling and approval of suppliers and clients, Maintain and approve service level agreements and technical agreements, Maintain the cold chain system.
MANAGEMENT REPRESENTATIVE (ISO 9001 AND 13485)
- The development, implementation and maintenance of the quality management system.
- Reporting on the performance of the quality management system to management for review and as a basis for continuous improvement.
- The promotion of customer requirements throughout the organization.
- Quality Assurance functions.
- Supplier monitoring and evaluation.
- Coordinating of internal and external audits.
- Issue and control of all quality documents, internal and external.
- Customer surveys and customer complaints.
- Preparation of summaries for management review.
- Corrective, preventive and improvement action systems.
- Identification of business and process risks.
OCCUPATIONAL HEALTH AND SAFETY ACT (16.2)
- Authority to act on behalf of the CEO and employer to ensure that the set objectives are met by the employer in an effective and efficient manner and in accordance with the legal and specified requirements (including the policies and procedures of the employer).
- Authority to make further legal appointments on behalf of the CEO and employer.
Minimum Requirements
Qualification:
Ideal:
- Business Management Experience/Qualification
Experience:
- 2-3 years’ experience within the pharmaceutical industry, coupled with a strategic outlook and specific focus on GWP.
- Advanced Computer Skills.
- Managing large groups of people.
Licensing & Accreditation:
- Need to be registered at SAPC.
Training Required:
- Training on company systems (e.g. Advanced Knowledge of the Kawari APP, Warehouse Management System (WMS) ESS, Eco-Time, SOP’s (All KDC SOP’s), Company Policies and Procedures and SLA’s).
Job Types: Full-time, Permanent
Application Deadline: 2024/10/20
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