Nonhle Zwane

• Evaluated regulatory report reviews, compiled data packs for e-/CTD submissions, and communicated with relevant parties to ensure availability of all necessary documentation for product registration or amendments in international and local markets.
• Ensured regulatory compliance by submitting variations for dossier maintenance and contributing to new product development.
• Ensuring comprehensive assessment of all necessary factors for oral, topical and sterile dosage forms in adherence to industry standards.
• Maintained and compiled information in regulatory documentation databases and information management systems to ensure compliance with regulations.
• Delivered administrative support to the Regulatory Affairs Department, ensuring compliance with Standard Operating Procedures (SOP's) through meticulous management of regulatory documentation.
• Provided assistance to the successful resolution of regulatory authority concerns.

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• Maintained adherence to GMP standards across all aspects of production and packaging.
• Ensured trending deviations are recorded and investigated promptly, as well as initiating change controls or CAPAs to ensure compliance
• Ensured compliance with production procedures, while accurately completing BMR and Control Records.
• Enhanced productivity and yield while minimizing losses and down time; oversaw production planning and execution of set targets.
• Ensured adherence to Health and Safety procedures and enforced proper use of PPE
• Conducted training sessions on production standard operation procedures and health and safety for staff members.

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• Verifying the dispensing of materials and its mass or volume.
• Ensured compliance with safety standards and procedures by closely monitoring production processes.
• Reviewed and approved SOP's while ensuring their implementation in line with local regulations (SAHPRA / SAPC).
• Monitored entire production process, ensuring ongoing compliance to GMP and upholding integrity of Quality Management Systems as per SOP’s (ISO9000/9001).
• Initiated new SOP workflows on QUMAS and implemented changes to Wok Flow Controls (WFC’s) and Standard Operation Procedures (SOP’s) in response to evolving manufacturing procedures, processes, and equipment.
• Reduced yield losses by investigating incidents resulting in non compliance and implementing structured problem solving.
• Conducting internal GMP audits, writing report on the audit and implementing corrective actions and controls where necessary.

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• Managed pharmacy inventory and stock management documentation registers while monitoring dispensing software (Rx Solution).
• Ensured accurate storage and preservation of stock to maintain potency and safety.
• Enhanced accuracy through implementation of quality assurance procedures, ensured constant adherence to infection control measures, while monitoring temperature and humidity in parallel for maintaining optimal cleanliness.

• Ensured compliance with hospital and air laws by accurately preparing, compounding, and dispensing medications.
• Ensured compliance with company, state, and federal regulations.
• Delivered comprehensive medication consultations to clients covering topics such as drug interactions, contra-indications, and appropriate storage.
• Maximized customer satisfaction through effective communication and collaboration with various stakeholders.
• Processed all paperwork accurately for claim submissions to medical aids.

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Under supervision of qualified Pharmacist:

• Prepared and dispensed medications while counseling clients on medication use and potential interactions
• Managed and conducted ward rounds and stock take in both the wards and pharmacy.
• Ensured efficient management of drug supply and adherence to regulations for schedule 5 & 6 medicines.
• Ensured proper storage of medications based on FEFO principles to maintain medication quality and patient safety.
• Enhanced accuracy by implementing effective quality assurance procedures.
• Worked closely with pharmacy management to optimize customer satisfaction by implementing procedural modifications.