Shonisani Lambani

• Screen and evaluate the quality and efficacy aspects of the quality variation applications for the registered medicines and generate evaluation report for each application
• Evaluate applicant responses and variations for the registered medicines
• Peer-review reports done by other reviewers and where necessary present at advisory committee
• Assessment of once off deviation requests in terms of Regulation 53 (2) of the Medicines and Related Substance Act
• Develop and update guidelines, SOPs
• Participate in special projects i.e

- Zazibona, GHPP pharmatrain project, RIMS

- Developed PHE guideline, update SOP’s

- Developed terms of reference for working and evaluation group

- Liase with other SADC countries and contribute on their EUA guidelines

- IPRP Project 17b review, consolidation of data form member countries and analyses

- Organise, lead meetings and advise on related matters

• Maximized performance by monitoring daily activities and mentoring team members. Refer to duties for Medicines Registration Officer for activities overseen.

• Technical screen and evaluate the quality and efficacy aspects of new applications for the registration of medicines
• Generate screening/evaluation report for each application
• Send report to second evaluator for peer review
• Evaluate applicant responses and variations for registration/approval of medicines

• Monitor compliance with the provision of the medicines Act and other Health related Acts
• Conduct inspections on facilities for cultivation of medicinal cannabis and generation of inspection reports and participate on cannabis licensing peer reviews
• Conduct inspections on pharmaceutical companies as well as other places where schedule 5,6,7 substances are kept
• Coordinate and manage the review and approval process of import, export, research and possession permits on Narcotics and Psychotropic substances
• Supervise and Training of admin personnel on issuance of Section 22A Permits and training of community service pharmacist on regulatory compliance
• Perform Post marketing surveillances, Investigate complaints regarding contravention of the medicines Act, prepare expert reports and attend to cases for prosecution in terms of the relevant health acts
• Liase with International Narcotics Control Board(INCB), prepare quarterly and annual reports for the INCB
• Foster, provide regulatory advice and develop networks with pharmaceutical industry, other regulatory authorities and relevant stakeholders
• Develop and review of Standard Operating Procedures (SOP) and guidelines
• Assist with analysing and approval of section 36 applications
• Assist in the preparation of audits for the Auditor-General
• Assist Port Health in evaluation of pharmaceutical products being imported to and exported from South Africa and issuance of release letters

• Accomplished multiple tasks within established timeframes
• Maximised performance by monitoring daily activities and mentoring team members
• Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery

Refer to Medicines Control Officer duties for activities overseen.

• Manage compliance with the Medicines and Related Substances Act, Act 101 of 1965 and as subsequently amended, as it relates to GWP, storage and distribution of cold chain of S5 and S6 medicines
• Perform all functions relating to a pharmacist, including ensuring appropriate checking, compliance and accuracy of all medicines handled
• Ensure that there is continuous Pharmacist supervision of premises during operating hours
• Ensure that orders are correctly, accurately and timeously picked and ensure that the batch number and expiry date as per the customer’s invoice is correct and corresponds
• Assist in preparing and updating SOP’s, conducting self inspection audits, conducting staff training and preparing for audits by third parties
• Ensure safe and effective storage and keeping of medicines and scheduled substances in the warehouse
• Handling of complaints and queries by clients

• Company Overview: Department of health, Limpopo
• Receiving, interpreting and filing prescriptions for day to day patients
• Counselling of patients on drugs dispensed
• Maintaining accurate inventory level
• Preparing chronic medications to clinics
• Provision of pharmaceutical supplies to the wards
• Liasing with other health care professionals to ensure the most appropriate treatment is delivered
• Ensuring medicinal products are stored appropriately and securely
• Responding to medication-related queries from within the hospital and clinics
• Department of health, Limpopo

• Company Overview: Department of health, Limpopo
• Receiving, interpreting and filing prescriptions for day to day patients
• Counselling of patients on drugs dispensed
• Maintaining accurate inventory level
• Preparing chronic medications to clinics
• Provision of pharmaceutical supplies to the wards
• Liasing with other health care professionals to ensure the most appropriate treatment is delivered
• Ensuring medicinal products are stored appropriately and securely
• Responding to medication-related queries from within the hospital and clinics
• Department of health, Limpopo

• Monitoring production activities and ensuring compliance with GMP
• Coordinating with production manager and plan manufacturing processes
• Ensuring availability of raw and packaging materials
• Ensuring the general cleanliness and hygienic conditions of manufacturing areas
• GMP training of production personnel
• Instructing and educating employees on safety measures
• Auditing of master batch documents(production and packaging)
• Compilation of deviation and investigation reports when required