Distribution Responsible Pharmacist

Job category: Other: FMCG, Retail, Wholesale and Supply Chain
Contract: Permanent
EE position: Yes
Introduction We are seeking to appoint a Distribution Responsible Pharmacist . The candidate will report into the Quality Compliance Executive.
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, and any guidelines promulgated in terms of these Acts, as relates to the procurement, storage, assembly, distribution and delivery of Medicines (as defined in the Act), ensure compliance to GWDP//GPP/GMP principals and continuous Pharmacist supervision during operating hours and to ensure emergency services available at the specific branch
Key Performance Areas:  • 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 and any guidelines promulgated in terms of these Acts, as relates to the procurement, storage, assembly, distribution and delivery of Medicines (as defined in the Act).
• Ensure compliance to GWDP/GPP/GMP principals: by performing batch recalls/withdrawals, self inspection audits, temperature mapping and validation and calibration of equipment required for GPP / GWDP/GMP adherence.
• Ensure that there is continuous Pharmacist supervision of premises during operating hours.
• Manage other Pharmacists and Pharmacist Assistants employed at the specific site.
• Ensure emergency services are available at the specific branch, perform call out duties and manage processes required to deliver the emergency services to Key Hospital customers.
Duties: 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, as relates to the procurement, storage, assembly and distribution of Medicines. (as defined in the Act)
• Understand the requirements of the Medicines and Related Substances Act, Act 101 of 1965 and Pharmacy Act, Act 53 of 1974 and as subsequently amended and keep up-to-date with amendments to these Acts.
• Ensure that the required registrations, recordings and licenses are current and in place for the specific UPD branch.
• Ensure that UPD's Standard Operating Procedures and processes related to receipt delivery, distribution and handling, storage, processes and procedures do not compromise or adversely affect safety, efficacy and quality of medicines/Scheduled products stored in the specific UPD warehouse/ Distribution Centre and that medicines and Scheduled substances are safely and effectively stored. Ensure that these processes and procedures do not subject the product/s to contamination and/or deterioration.
• Conduct new customer validations and regular documented reviews of customer access to scheduled medicines, to ensure that customers that access scheduled medicines are legally entitled to do so. Ensure that there are systems, particularly security systems, in place to prevent unauthorized persons accessing the premises and scheduled medicines outside normal working hours both during working hours and after hours which includes security and staff search procedures
• Maintain the Site master file for the specific UPD branch. Establish and maintain, the Quality Manual for the specific UPD branch.
• Ensure that contracts/SLA's are in place exist between the UPD and /or UPD distribution (contract giver) and all 3rd party contractors (contract acceptor) stipulating the responsibilities in terms of GWDP. SLA'S are required for amongst others Rodent and pest control, Cleaning services, Couriers and freight forwarding (including any third party services); Calibration services; Fire extinguishers Waste disposal; Preventive maintenance of critical equipment Security; and IT.
• Perform Vendor audits on local 3rd party contractors when required
• Liaise with the Inspectors of the Medicines Control Council and South African Pharmacy Council, 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, Medicines Control Council, other internal and external audits and Self Inspection audits. Document short comings indentified during these audits using the required UPD Format. Prepare responses to these audit observations, and ensure follow to close out all observations takes place according to agreed timelines.
Duties: Ensure compliance to GWDP/GPP/GMP principals : by performing batch recalls/withdrawals, self inspection audits, temperature mapping and validation and calibration of equipment required for GPP / GWDP/GMP adherence.
• Monitor and control the distribution of SOP's and ensure strict implementation of SOP's. including but not limited to: Control of stock – involving Management in terms of SOP's and Legislation of: Hazardous substances, Schedule 6's and Schedule 5's (as specified), Cold Chain maintenance, expiry date, batch tracking/traceability control and stock rotation. Including, management of discontinued or expired Medicines, Recalled medicines and medicines returned to the Branch or Medicines damaged and / or expired at the Branch and the formal destruction of these Medicines.
• Ensure that 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 that where product is in quarantine, that the status is maintained for the full period prior to release for sale and that the stock is locked away/inaccessible for the duration of that period in terms of UPD SOPs. Ensure that where Distribution clients' stock is received and stored in quarantine that releasing of this stock for sale is done according to UPD SOPS and in terms of SLAs and technical agreements with the Distribution client/s.
• Ensure high standards of housekeeping, pest control and cleanliness is maintained in the warehouse and that immediate cleaning of spillages in terms of the Standard Operations Procedures take place.
• Conduct monthly documented Self Inspections Audits in terms of UPD SOP's, to monitor compliance. Document short comings indentified during these audits using the required UPD Format. Prepare responses to these audit observations and ensure follow to close out all observations takes place according to agreed timelines.
• Ensure that Effective Risk Management processes are in place to allow the risks to be controlled, which includes security processes, continual supply of power to fridges, air conditioners and alarm and IT systems.
• Monitor and ensure safe and effective storage and audit special storage, storage and delivery temperatures and conditions to protect products against spoilage, spillage, contamination and deterioration and ensure that correct storage temperatures are maintained. Analyze data derived from monitoring these conditions and inform the Branch Manager and Managing Director of deviations from specifications and make recommendations for any changes required.
• Receive alarm signals alerting a possible out of specification temperature, breach of cold chain and failure of equipment and for implementing together with the Branch Manager, the SOPs specific to temperature deviations/excursions; Advise the Branch Manager and Managing Director of any temperature deviations/excursions and investigate causes and produce a formal report documenting the reasons for the temperature excursion and make recommendations to prevent recurrence of the same.
• Ensure that daily inspections of fridge/freezers are performed to ensure compliance to the relevant SOP's.
• Conduct a weekly documented review of compliance with cold chain packaging protocols.
• Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of products, medical devices or IVDs.
• Ensure that adequate systems and effective record keeping are in place ensure adherence to FEEFO/FIFO batch rotation requirements to ensure batch traceability. Monitor and audit these systems and processes to ensure maintenance of correct batch traceability records. 
• Administer and coordinate batch recalls/withdrawal activities and document the outcomes.

• Conduct and document "mock" recalls at least twice a year to test adherence to UPD SOP's and timelines, identify areas of possible delays and/or non compliance and propose and implement solutions to these observations.
• Ensure that product returned is correctly handled, the reasons for return are documented and follow up actions and recommendations are documented and communicated. Evaluate product returned for credit and make the final decision as to whether these products may be returned to saleable stock or if they must be destroyed. 
• Manage the process for the destruction of damaged, unsalable and unsafe stock and maintain the documentation required to confirm destruction of these products ensure that the appropriate waste disposal method and location is selected in accordance with the provisions of the Nuclear Energy Act, 1982 (Act 92 of 1982), the National Environmental Management Act, 1998 (Act 107 of 1998), the Waste Act, 2008 (Act 59 of 2008) and the Air Quality Act, 2004 (Act 39 of 2004); and other legislation in terms of local municipal Regulations. 
• Accompany the goods to the disposal site as specified by the Authority, witness the disposal and obtain a "Destruction Certificate". 
• Be an active Member of the SOP Committee and involved in investigating, making recommendations relating to, establishing and updating SOP's and policies with regards to Acts and services provided by UPD. 
• Ensure that all personnel involved in wholesaling or distribution activities are trained in the requirements of Good Wholesaling and Distribution Practices and be capable of meeting these requirements and that this training is documented. Reviewing on a regular basis the effectiveness of the training programs;
• Evaluating the relevance of the course content e.g. training on Storage and Handling etc; Identifying which staff will be entered into the training programs; Monitoring whether staff has participated as planned in the training programs; Personnel should receive initial (induction) and continuing training relevant to their tasks, and be assessed as applicable, in accordance with a written training program; 
• Ensure that all product complaints are kept on file and are forwarded onto the applicant or holder of the certificate of registration. Address and resolve any technical complaints relating to the storage and handling of stock from customers, clients and/or the MCC. 
• Perform temperature mapping and temperature monitoring of ambient and cold chain facilities, analyzing results and investigating temperature excursions/deviations and ensure that appropriate validations of equipment and processes is conducted.
• Arrange and manage annual calibration of monitoring and other equipment in terms of UPD SOP's.
Duties: Ensure that there is continuous Pharmacist supervision of premises during operating hours
• Ensure that in the event of your absence from the premises a suitably qualified Pharmacist is on site. Ensure that a signed written delegation of authority to that Pharmacist is in place and ensure that the Pharmacist is given a copy of the job description. Where necessary, appoint a Locum Pharmacist and ensure that the Locum has the appropriate qualifications and experience and is trained in the relevant UPD SOP's in order to perform the duties of a Pharmacist in terms of the Pharmacy Act and the regulations to this Act.
• Ensure that in the absence of any other Pharmacist/s from the specific UPD branch that suitably qualified Pharmacist/s are appointed to ensure that the duties of that Pharmacist/s are carried out and that UPD's ability to service its customers and distribution clients is not compromised and that compliance with the prevailing legislation, GWDP/GMP/GPP is complied with.
• Ensure that premises and all Pharmacists including locum Pharmacists and Pharmacist assistants, employed as Pharmacists and Pharmacist assistants, are currently and appropriately registered with the SA Pharmacy Council.
• Assist with the appointment of appropriately qualified and experienced Pharmacists for the specific UPD branch. Ensure that appropriate training of the Pharmacists in your specific Branch takes places. Where appropriately experienced Pharmacists are not available, suitable supervised classroom and on the job training must be provided prior to such Pharmacist taking on responsibilities of Responsible Pharmacist in a specific area or of the Managing Pharmacist.
• Notify South African Pharmacy Council when services within UPD of any Pharmacist, employed as a Pharmacist, and particularly your own have been or will be terminated.
Duties: M anage other Pharmacists and Pharmacist Assistants employed at the specific UPD branch.
• Oversee the daily activities of other Pharmacists appointed as responsible Pharmacists in specific areas where the quality, safety and efficacy of medicines could be affected
• Manage and control S6 and specified S5 products including receipt, storage, and dispatch of these products
• Perform monthly checks to ensure that the Schedule 6 (HFD) and Specified Schedule 5 (as determined by Legislation) registers are properly maintained and balanced
• Ensure that accurate, timely assembly of orders for S5.5 and S6 products and correct packing and dispatch of these orders, in terms of UPD SOPs and legislative requirements in order to meet Operational cut off times.
• Check, balance and sign off S5.5 and S6 registers even month and ensure balancing of these registers is completed in terms of the legislative requirements.
Duties: Ensure emergency services are available at the specific branch, perform call out duties and manage processes required to deliver the emergency services to Key Hospital customers.
• Perform on call duties for the emergency services provided by UPD for Key Hospital customers
• Ensure that suitably trained Pharmacists available to cover emergency service call outs in the event that any of the Pharmacists.
• Ensure that usage of these services is monitored and any abuse reported to the Customer Key Account Executive
• Ensure that there is sufficient stock of the emergency lines in the specific UPB branch ensure that emergency orders are received by the Key hospital customer as soon as possible after the request and that this happens within delivery window agreed in terms of the SLA with these key customers
Skills: · Current valid registration in good standing with SAPC
· Management/supervisory skills
· Analytical and problem solving skills
Knowledge: · Pharmaceutical wholesale and distribution
· Pharmaceutical Industry Laws, regulations and Ethics
· Ability to work in a team
· Ability to work under pressure
· Honesty and integrity
· Ethical
· Legal compliance
B. Pharm
Minimum Job Related Experience: 5 years experience in wholesale Pharmaceutical Industry
N.B: We endeavor to provide feedback to all candidates whenever possible, however, if you don't hear from us within 14 days from the closing date, please consider your application unsuccessful. Do you require help with the registration process?
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