Responsible Pharmacist

4 months ago

Cape Town, South Africa NEOC Digital Full time

Our Client is looking for a Responsible Pharmacist who will join they team in the Cape Town area.

**_DEFINITION:_**

**_Section 1 of the Pharmacy Act, 1974 (Act 53 of 1974):_**
“Responsible Pharmacist” means 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, Act 53 of 1973, 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 and who is registered as such in terms of the Act.

Regulation 1 of the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965):
“Responsible pharmacist means a responsible pharmacist as defined in the Pharmacy Act, 1974 (Act 53 of 1974)”
- Regulation 28: The Responsible Pharmacist contemplated in regulation 25(3) must:_
- Ensure that he or she in fact continuously supervises the pharmacy in which he or she has been appointed.
- Have appropriate qualifications and experience in the services being rendered by such pharmacy.
- Ensures that persons employed in such pharmacy and who provide services forming part of the scope of practice of a pharmacist are appropriately registered with council.
- Notify council immediately upon receiving knowledge that he/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; and
- In addition to the general responsibilities also:

- Ensure that unauthorized persons do not obtain access to medicines or scheduled substances of 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 substances in the pharmacy under his or her direct personal supervision; and
- Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances.

**PRINCIPLE DUTIES**

**1. LEGAL**
- To ensure registration of RP and licensing of the company with Authorities.
- To ensure name of RP is prominently displayed over entrance.
- To ensure that the pharmaceutical facility is conducted under the continuous supervision of a pharmacist (legal requirement).
- To ensure that a Designated Deputy RP (DDRP) is in control of the facility should the RP be absent.
- To ensure that directors (when applicable) are au fait with the latest ethical rules of SAPC, the SA Guide to GMP and sign agreements to abide thereby.

**2. PHARMACOVIGILANCE**
To ensure that product complaints involving "adverse drug reactions" or “adverse events” are reacted upon and followed up without delay in accordance with the regulatory guidelines and company SOPs.

**3. RECALL**
- To be able to handle a medicine recall or withdrawal according to correct procedure.
- 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 make the final decision on a recall with SAHPRA..
- To ensure that SAHPRA is immediately informed of any possible withdrawal of unwanted medicine from market.

**4. PRINTED PACKAGING**
- To ensure that all printed packaging is reviewed, updated, and approved.

**5. STABILITY**
- To ensure that all stability processes and protocols are adhered to.

**6. PRODUCT REGISTRATIONS**
- To ensure that necessary updates are made to the registration dossier according to latest requirements of the SAHPRA.
- To ensure that the Registrar is informed of changes to the registration dossier.
- To ensure master documentation exists for each product and is kept up to date.
- To ensure that all master documentation complies with the registration dossier and is current.
- To ensure that the location of registration master documents and copies thereof are recorded and maintained and controlled in a correct manner.
- To ensure that master documentation exists for each product and that standard operating procedures are correctly authorized.

**7. OCCUPATIONAL HEALTH AND SAFETY**
- To comply with and implement all company and departmental occupational health and safety regulations and SOPs

**8. IMPLEMENT AND MAINTAIN cGxP**

**9. MEDICAL DEVISES**
- Ensuring registration and compliance with relevant authorities for In vitro diagnostics (IVDs) and non-IVD medical devices.
- Must meet strict regulatory requirements and ensure products comply with safety and efficacy standards, ISO 13485 certified, CE and FDA
- Maintaining documentation of specifications and procedures, advising internal team on regulatory and quality issues
- Keeping up to date with latest local and international standards
- Provide training on all aspects to medical de

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