Khomotso Kutumela
Regulatory Affairs Pharmacist
Pomona
Summary
Regulatory Affairs Pharmacist with a Master's in Pharmaceutical Sciences and expertise in ensuring compliance for medical devices and pharmaceuticals. Proficient in preparing and submitting regulatory documentation, conducting risk assessments, and managing post-market surveillance. Knowledge of SAHPRA, EMA, and ISO regulations, consistently upholding quality assurance standards. Highly effective communicator experienced in liaising with regulatory bodies and internal teams. Excited to contribute to a team assessing applications using technical screening forms to ensure compliance with established guidelines.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Pharmacist
Henry Schein Dental Warehouse
2 2024 - 9 2024
- Ensured that medical devices comply with relevant regulations and standards including ISO 13485 and SAPHRA regulation
- Establishing, maintaining and reviewing pharmacy procedures in accordance to GMP, ISO 9001 and SAHPRA regulations
- Prepared and submit regulatory documentation, including pre-market notifications, pre-market approvals (PMA) according MDR EU regulations and SAHPRA regulations
- Conducted risk assessments to identify and mitigate potential issues associated with the medical device
- Managing and reviewing product PI to ensure compliance with regulatory guidelines
- Collaborate with quality assurance teams to develop and implement standard operating procedures (SOPs) related to regulatory compliance
- Participate in internal and external audits and inspections by regulatory agencies
- Provide training to internal teams on regulatory requirements and compliance issues.
Hospital Pharmacist
HA Grove Hospital
02.2023 - 02.2024
- Ensuring the safety and effectiveness in operations of the
- Establishing, maintaining and reviewing pharmacy procedures
- Dispensing, ward stock replenishments including a variety of medical devices in the hospital
- Managing cross-functional relationships with prescribers, suppliers
- Utilized excellent communication skills to explain complex medication instructions to patients
- Incorporated principles of pharmaceutical medical science to ensure the safe and effective use of medications, reducing potential drug interactions and adverse events
- Implemented a variety of South African Health and Safety protocols in line with Act 101 of 1964 standards
- Monitoring compliance of GPP compliance and GCP of QPB
- Led learner pharmacist assistant students which resulted in the career development of the students qualifying as QPB
- Regularly ordered and received stock using RX Solution including Schedule 6 according to
Pharmacist Intern: Academic Internship
Tshwane University of Technology
01.2019 - 01.2024
- Used excellent written skills to create a comprehensive dissertation for my master's degree
- Developed a new drug formulation to improve oral delivery of protein drugs, tested in vitro drug release of nano - and micro-based
- Coordinated research protocol and design strategies for my project: protein drugs, tested in vitro drug release of nano - and micro-based
- Presented research finding using Microsoft PowerPoint & Excel
- Organized online and contact classes for undergraduate pharmacy students
- Utilized Microsoft Excel to organize and manage research data findings for pharmacokinetic properties of each formulation
BPharm Teaching Facilitator
Tshwane University of Technology: Department of Pharmaceutical Sciences
01.2019 - 12.2022
- Led Bachelor of Pharmacy students in teams of up to 10 students through problem-based learning (PBL) scenarios, resulting in students' ability to solve pharmacy-related problems by applying knowledge acquired in class
- Maintained excellent attendance record, consistently arriving to work on time
- Devoted special emphasis to preparation and punctuality to arrive to work ready to start immediately and be acknowledgeable
Education
Master - Pharmaceutical Sciences
Tshwane University of Technology
Bachelor of Pharmacy - Pharmacy
Tshwane University of Technology
Skills
- Well knowledgeable in pharmacokinetic evaluation of drug formulation
- Working autonomously
- Pharmaceutical calculations including bioequivalence
- Attention to detail
- Drug safety, Quality and Bioequivalence
- Good Manufacturing Practice
- Visionary and Self-Motivated
- Detail orientated
- Multitasking
Data Tracking
Certification
Registered pharmacist, South African Pharmacy Council, 02/2023, P49706
Languages
English
Bilingual or Proficient (C2)
IsiZulu
Upper intermediate (B2)
IsiNdebele
Intermediate (B1)
References
- Mr. Jermaine Mombeshora, QMS and ISO compliance Pharmacist, Henry Schein Dental Warehouse, Jermaine.Mombeshora@hernyschein.co.za, 084 541 8785
- Ms. Nozipho Dladla, Responsible Pharmacist, Mpumalanga Department of Health- HA Grove Hospital, Nozipho.dladla2@gmail.com, 076 556 9078
- Professor Clemence Tarirai, Research project supervisor, Tshwane University of Technology, Tariraic@tut.ac.za, 073 092 0855
Projects
Formulation of Nano- and Micro-based Smart Pharmaceutical Technologies For Oral Protein Delivery, 01/2019, 01/2023, Master of pharmaceutical science research project, focusing on nanomedicine for improved oral delivery of protein-based biopharmaceuticals. The nanoparticles were formulated using novel drug delivery systems, including Chitosan, cotton wool and cellulose.
Volunteer Experience
2nd Year Pharmacy Student, Adcock Ingrams, Midrand, 10/2016, 11/2016, Examined incoming materials and compared to documentation for accuracy and quality., Conducted performance and quality assurance tests of goods to meet product certification requirements., Inspected finished products for quality and adherence to customer specifications., Evaluated components and final products against quality standards and manufacturing specifications., Work in the dossier room, arranging and recording dossier from CTD to eCTD
Timeline
Hospital Pharmacist
HA Grove Hospital
02.2023 - 02.2024
Pharmacist Intern: Academic Internship
Tshwane University of Technology
01.2019 - 01.2024
BPharm Teaching Facilitator
Tshwane University of Technology: Department of Pharmaceutical Sciences
01.2019 - 12.2022
Regulatory Affairs Pharmacist
Henry Schein Dental Warehouse
2 2024 - 9 2024
Master - Pharmaceutical Sciences
Tshwane University of Technology
Bachelor of Pharmacy - Pharmacy
Tshwane University of Technology
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