Responsible Pharmacist

4 weeks ago

Midrand, South Africa Medipost Pharmacy Full time

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 need to ensure Kawari remains complaint to 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 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.

**The following are the primary responsibilities of this person;**

**GOOD WHOLESALING AND DISTRIBUTION PRACTICES**

**1). REGULATION 28**:The Responsible Pharmacist contemplated in regulation 25(3) must**:

- Ensure that he or she in fact 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 is appropriately registered with council.
- Notify council immediately upon receiving knowledge that his/her services are 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 and

In addition to the general responsibilities also:

- Ensure that unauthorised 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 schedules substances.

**2) 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 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 text books are on hand (SAPC requirement)
- Ensuring that quality, efficiency and safety and pharmaceutical products are maintained through the distribution chain.

**3) COMPLAINTS**
- To ensure that all product complaints are investigated and identified as to the nature of the problem and is given the necessary attention.
- To ensure that the 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.

**4) 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 batched 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, counterfeit medicine in/from the market.

**5) 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 of all quarantined goods i.e. returns, rejects etc.
- To ensure that the disposal or destruction o

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