Xenia PharmaceuticalResponsible Pharmacist | QA Manager
Jan. 2021 - Nov. 2021Demonstrated attention to detail, regulatory expertise, and strong communication skills in engaging with authorities, clients, and internal teams in the veterinary medicines sector. Collaborated with formulators and chemists to develop and commercialise products for large retail chains. Maintained adherence to local and international regulatory standards, including ISO9001:2015, Feeds guidelines, Agricultural Remedies & Stock Remedies Act 36 of 1947, and the South African Pharmacy Council regulations. Obtained and maintained the pharmacy license and necessary documentation, including marketing authorisations for veterinary products registered with DALRRD. Reviewed manufacturing processes, testing results, documentation, and batch releases to ensure safe and high-quality animal-use products, conducting rework investigations as needed. Investigated complaints and adverse events, implementing CAPA as needed. Qualified suppliers, manufacturers, and vendors, and assessed raw materials to ensure quality, compliance, and expand offerings. Trained 30 operators on regulations, quality standards, and best practices. Established and maintained an accessible online QMS for ease of desktop audits, including procedures, processes, and documentation. Formulated and ensured adherence to cloud-based process-specific SOPs, ensuring periodic revisions aligned with regulatory requirements. Conducted internal audits for QMS and regulatory compliance, including ISO9001:2015 recertification, SAPC GPP compliance, and DALRRD audits. Oversaw CAPA processes for deviation resolution and complaint management. Steered change control processes to integrate improvements without compromising quality. Validated and qualified equipment, processes, and facilities in line with regulatory requirements. Implemented ISO9001:2015 compliant risk assessment processes to identify, evaluate, and mitigate risks. [Kindly be advised, further details available upon request (Comprehensive CV)]