Simamkele Mnguni

Goal-oriented, dependable, and adaptable pharmacist with experience in pharmaceutical manufacturing, packaging, quality compliance, and dispensing. Currently working as a Compliance Pharmacist, with hands-on experience in electronic batch record review, deviation investigations, customer complaint management, CAPA implementation, and GMP compliance. Proficient in PAS-X (Electronic Batch Record System), Veeva QualityDocs (deviations, customer complaints, CAPAs, SWIs, and SOP management), DCS/SCADA systems, and SAP for stock management.

Recognised for strong analytical, problem-solving, and organisational skills, with the ability to collaborate across cross-functional teams to ensure product quality, regulatory compliance, and operational excellence. Seeking to further develop a career within the pharmaceutical manufacturing industry by contributing to continuous improvement initiatives, quality assurance, and the production of safe, high-quality medicines.

Compliance Pharmacist at Haleon (2024-01 – Present)

• Ensure compliance with GMP, Pharmacy Act, and Medicine Act requirements in production processes.
• Update SOPs, create job aids, and manage production documentation.
• Conduct risk assessments, implement CAPA actions, and resolve customer complaints.
• Oversee batch documentation and coordinate deviations, change controls, and continuous improvements.
• Deliver training on SOPs and Health and Safety, promote adherence to quality standards.
• Perform, review and approve line sign-Ons, closures, and clearance authorization.
• Ensure that 5W1H/ QRAP/ RCA is completed after machine downtime with possible product impact.
• Ensures production process adherence to standards and specifications by monitoring adherence to guidelines, procedures, and document controls.
• Daily inspection of departmental housekeeping and SOP's and Logs.

Community Service Pharmacist at Ekombe Hospital, KZN Department of Health (2023-01 – 2023-12)

• Provided pharmaceutical care, including prescription evaluation and patient counseling.
• Managed medication dispensing in line with SOPs for quality assurance.
• Responsible for the management, ordering, control, and handling of stock. Cold chain management.
• Conducted clinic assessments and supported local clinics, enhancing patient safety.
• Participated in the hospital's Pharmacy and Therapeutics Committee (PTC), contributing to adherence to therapeutic guidelines and antimicrobial stewardship.
• Monitored and maintained stock levels of medicines and supplies (by use of stock cards) to meet expected demand.
• Compounding.

Pharmacist Intern at Netcare Pinehaven Hospital, Krugersdorp (2022-01 – 2022-04)

• Assisted in dispensing medications, patient counseling, and prescription verification.
• Supported ward pharmacists in conducting ward rounds, ensuring accurate medication administration.
• Maintained accurate patient records and prepared reports on medication usage.
• Completed section 21 medication applications, controlled section 21 drugs and ensured drug safety through pharmacovigilance.

Production Pharmacist Intern at GlaxoSmithKline (2022-04 – 2022-12)

• Assisted with production operations, including line clearance and batch documentation.
• Collaborated closely with compliance and quality teams to uphold GMP standards.
• Gained practical knowledge in production processes and pharmaceutical quality assurance.
• Managed reworks.

Bachelor of Pharmacy in Pharmacy – University of the Western Cape (UWC) (2021)

Matric Certificate – Kasselsvlei Comprehensive High School (2016)