Kholofelo Sono

I am responsible for ensuring all products are released for sale according to Good Manufacturing Practice (GMP) requirements and within set timelines. Performing the functions of the Responsible Pharmacist (RP) in their absence. Warranting pharmaceutical quality and compliance.

Key responsibilities include:

• Ensuring compliance with the legislative requirements as set out in the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974.
• Assisting the RP with both Quality Assurance and Regulatory activities for new and existing pharmaceutical products.
• Ensuring compliance with all regulations and guidelines pertaining to the Import/ Export license for medicinal products and that Good Manufacturing Practices, Good Housekeeping Practices, Good Pharmacy Practice, Good Distribution Practices and the Marketing Code is constantly adhere to.
• Ensuring that all relevant SOPs are in place to meet Corporate Quality Manual requirements and ISO 9001.
• Compilation of release documentation and release of all products.
• Investigate non-conformances and implement Corrective Actions and Preventive Actions as identified.
• Participation in deviation classifications and investigations, Quality Risk Management and Change Control Systems.
• Participation in Health Authority and quality audits.
• Responding to the requests of both internal and external customers adequately, satisfactorily and timeously.
• Participation in and leading meetings, problem solving sessions and strategy development plans with company representatives for which the Company operates as a Contract Manufacturing Organization.

Final approver of all manufactured and imported finished pharmaceutical products prior to sale.

I ensured that records are maintained to provide evidence of conformity to requirements and of the effective operation of the Quality Management System.

Key responsibilities include:

• Reviewing of batch manufacturing, packing, analytical records prior to batch release.
• Reviewing of Certificates of Analysis (COA), Certificate of Conformance(COC), Data loggers and Packing Lists from imported bulk and finished products.
• Generating Certificate of Conformance for Holders of Certificates.
• Reviewing of deviations, root cause investigations, incidents and Change Control.
• Identification and resolution of quality incidents, both internally and from outside suppliers.
• Ensuring ongoing compliance with relevant Acts, Regulations, Guidelines and Marketing Codes.
• Collaborating with the Quality Control, Warehouse, production teams and business units pertaining to set release dates.
• Management of Schedule 5 and 6 retention samples, storage and documentation.

I was the sole Pharmacist during a 12 hour Night-shift delivering Pharmaceutical care to patients and varied departments within the hospital.

Key responsibilities included:

• Interpreting prescriptions and dispensed medication in response to prescribers' orders.
• Rendering medication teaching to healthcare providers, patients, and families upon discharge.
• Managing drug supply inventories of mainly Anti-retroviral drugs and COVID vaccines in 15 clinics under the hospital.
• Conducted quarterly stock takes in the respective clinics and balancing of Schedule 5 and 6 substances on their registers.
• Liaising with Limpopo Province Pharmaceutical Depot for stock orders, ensuring cost-effective selection, verification, and timely delivery of medications in the hospital and feeding clinics.

I conducted intern duties under the professional supervision of registered Pharmacists. Rotated across various departments - Warehouse, Packaging, Dispensary, LCO, OSD, Quality Control, Quality Assurance, Validation, Pharmacovigilance, and Regulatory Affairs. Performing manufacturing operations in accordance with GMP standards, recording production data, completing and following batch records whilst complying with SOPs.

Key responsibilities included:

• Assisting in the day to day running of the production area, ensuring operations are maintained in line with the company Quality Management System, SOPs, Pharmacy Act and Medicines Act requirements.
• Supervising and delegating tasks to a team operators ensuring that all manufacturing activities were undertaken in line with GMP and to an exceptional quality standard, across a range of dosage forms including Solids, Liquids, Ointments and Creams.
• Completing daily compliance checks of batch documentation, equipment, and facility logbooks to ensure continual compliance.
• Approving commencement of manufacturing and packing runs after performing line clearance checks.
• Checking the correctness of raw materials - weights/volumes before initiating raw material dispensing.
• Conducting cyclic stock counts for Schedule 5 and 6 retention samples and balancing the register.
• Contributed to the updates and development of SOPs.
• Assisting in addressing Customer complaints, Root Course Investigations, Deviations and Change Control actions.