Responsible Pharmacist

**Listing reference**: 015943**Listing status**: Online-
**Position summary**

**Industry**:FMCG & Supply Management
- **Job category**:Other: FMCG, Retail, Wholesale and Supply Chain**Location**:Roodepoort
- **Contract**:Permanent**EE position**:Yes**Introduction**
- We are looking to recruit a permanent Responsible Pharmacist (QA Managing Pharmacist) to work for United Pharmaceutical Distributors (UPD). The role will be based at our Lea Glen, Roodepoort Branch and will report to the Quality Compliance Executive.**Job description**

**Job Purpose**:
To manage compliance with the Medicines and Related Substances Act, Act 101 of 1965 and as subsequently amended and the Pharmacy Act, Act 53 or 1974 and as subsequently amended, for both UPD Wholesale and UPD Distribution.

**Key Performance Areas**:

- Ensure compliance with legislation, regulations, guidelines and standards (including ethical rules and principles), governing UPD as a Wholesaler and Distributor of Medicinal products and medical devices.
- Develop, implement, and maintain the Quality Management System to ensure compliance with regulatory requirements and Quality Agreements with Distribution Clients
- Ensure that favourable audit reports are received from Distribution Clients and Regulatory Authorities, formulate replies to audits reports and ensure that all observations are addressed and closed out
- Ensure emergency services are available at the specific branch, perform call out duties and manage processes required to deliver the emergency services to customers.
- Manage Pharmacists, Pharmacist Assistants other pharmacy support personnel

**Quality Outputs of the Job**

Ensure compliance with legislation, regulations, guidelines, and standards (including ethical rules and principles), governing UPD as a Wholesaler and Distributor of Medicinal products and medical devices.
- Maintain required licenses, registration, and recordings necessary to operate the branch
- Maintain the Site master file, the Quality manual and legal records specified in the Pharmacy Act and Medicines and related Substances Act, for UPD Lea Glen
- Liaise with the Inspectors of the South African Health Product Regulatory Authority (SAHPRA) and South African Pharmacy Council(SAPC), as and when required and ensure full compliance with any recommendations and/or stipulations made by the Inspectors.
- Take corrective measures in respect of deficiencies identified with regards to inspection reports of the South African Pharmacy Council, South African Health Product Regulatory Authority, other internal and external audits, and Self Inspection audits.

**Duties**: Develop, implement, and maintain the Quality Management System to ensure compliance with regulatory requirements and Quality Agreements with Distribution Clients

Ensure implementation of the Quality Management System in line with South African Good Wholesaling Practice (SAGWP), ISO 9001 and ISO 13485 standards in respect of the following:

- Vendor and Customer verification
- Personnel training
- Self-inspections, Corrective and Preventive actions
- Validation, Calibration, Risk management and Changes controls
- Release and Quarantine
- Management Reviews
- Ensurethat correct, adequate and orderly storage of various categories of product, for example released, recalled, rejected and quarantine products, is in place and that these areas are clearly marked and adequately segregated.
- Ensure products are received and stored in quarantine where applicable and the release of products are performed as per SOPs and in terms of Service Level Agreements (SLAs) and technical agreements with the Distribution client/s.
- Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of products, medical devices or IVDs.
- Ensure that procedures for cold chain maintenance are in place from the time that products are receipted until they are delivered to customers.
- Ensure that all product complaints and adverse events/ drug reactions are kept on file and are forwarded onto the Manufacturer for attention and advice.
- Ensure destruction or disposal of products containing scheduled substances are conducted in such a manner that ensures that they are not retrievable.
- Ensure that counterfeit products / Stolen products are identified and the affected manufacturers, Regulatory Authority and the South African Police Service (SAPS) are notified.
- Ensure that recall procedures for products are in place to assist the manufacturer with the product recall. Conduct and document “mock” recall at least once year or on instruction from a distribution client to test adherence to UPD SOP’s and timelines.
- In conjunction with the Branch Manager, ensure that Effective Risk Management processes are in place and implement appropriate mitigation plans.
- Ensure that product returned is correctly handled, the reasons for return are documented and follow up actions and recommendations are document