Rilet Janse Van Rensburg
Plettenberg bay
Summary
Experienced Responsible Pharmacist and Compliance Specialist with 7+ years in pharmaceutical manufacturing, regulatory affairs, and GMP implementation. Proven track record in leading SAHPRA licensing, conducting audits, and managing Schedule 6 substances in line with PIC/S and ICH standards. Skilled in SOP development, validation lifecycle management, and team training across GMP, hygiene, and documentation practices.
Hands-on knowledge of clinical data handling and clinical programming, supported by coursework, self-led research, and applied learning. Familiar with CDISC standards (CDASH, SDTM), Python (pandas, matplotlib), and SQL for basic querying and data visualization.
Co-developed and validated the GMP Flower compliance system, highlighting strong project management, digital system thinking, and regulatory understanding.
Overview
7
7
years of professional experience
Work History
Responsible Pharmacist
CapeBud (Pty) Ltd
01.2023 - Current
- Engage with regulators for technical responses to SAHPRA observation reports using ICH Q9 (Quality Risk Management) framework.
- Project & Time Management: Led GMP system rollouts, validation planning, audit scheduling, and regulatory report submissions within strict timelines.
- Leadership & Team Management: Supervised compliance teams, conducted competency assessments, and delegated responsibilities to ensure operational efficiency.
- Training & Development: Designed and delivered SOP, GMP, hygiene, and regulatory training for QA, production, and packaging departments.
- Manage deviation, CAPA, and change control systems, including electronic CAPA tracking in line with PIC/S Part I Chapter 1 and 9.
- Develop and maintained a comprehensive SOP system based on ICH and PIC/S standards; ensured document control through GMP Flower (validated electronic QMS).
- eQMS Development: Co-developed GMP Flower; user role configuration, SOP workflow automation, audit log tracking.
- Data Integrity: Developed procedures aligned with ALCOA+ principles.
Responsible Pharmacist
Future Pharma Palmyra
04.2022 - 12.2022
- Managed the day-to-day pharmacy operations, ensuring regulatory compliance.
- Provided expert pharmaceutical care and patient counseling.
- Supervised inventory management and controlled substance protocols.
Clinical Pharmacist
CHRISTIAAN BARNARD HOSPITAL
01.2020 - 03.2022
- Collaborated with interdisciplinary healthcare teams for optimal patient care and improved treatment outcomes.
- Developed strong relationships with healthcare providers, facilitating communication and collaboration for better patient care coordination.
- Evaluated medication regimens for complex patients, identifying potential drug interactions and devising alternative treatment strategies when necessary.
- Educated patients on proper medication use and adherence, leading to improved health outcomes and decreased hospital readmissions.
Community Pharmacist
National Department Of Health
01.2019 - 12.2019
- Assisted patients with over-the-counter medication recommendations and responded to questions concerning drug interactions.
- Educated patients on over-the-counter product selection and proper usage, ensuring safe and effective self-care choices.
- Reduced medication errors through diligent prescription review and verification processes.
- Developed strong relationships with healthcare providers, resulting in improved patient care and communication.
Pharmacist Intern
Netcare Unitas
01.2018 - 12.2018
- Contributed to a positive work environment through effective teamwork and collaboration with pharmacy staff members.
- Utilized strong communication skills to educate patients on proper medication usage, potential side effects, and drug interactions.
- Used pharmacy software to enter prescription and insurance information.
- Maintained a clean, organized, and well-stocked pharmacy workspace, promoting an efficient workflow for all team members.
Education
B.Pharm - Pharmacy
North West University
Potchefstroom, South Africa12-2017
Skills
- Regulatory Compliance (SAHPRA, Act 101, Pharmacy Act)
- Good Manufacturing Practice (GMP), GACP-to-GMP Transitions
- Good Clinical Practice (GCP) Familiarity
- Internal & External Audit Management
- Schedule 6 Substance Control & Documentation
- Risk-Based Quality Management (ICH Q9)
- SOP Development & Document Control (ICH Q10, PIC/S)
- Validation Management (Process, Cleaning, Equipment)
- Clinical System Experience (eg, GMP Flower, EDC concepts)
Languages
English
Bilingual or Proficient (C2)
Afrikaans
Bilingual or Proficient (C2)
Timeline
Responsible Pharmacist
CapeBud (Pty) Ltd
01.2023 - Current
Responsible Pharmacist
Future Pharma Palmyra
04.2022 - 12.2022
Clinical Pharmacist
CHRISTIAAN BARNARD HOSPITAL
01.2020 - 03.2022
Community Pharmacist
National Department Of Health
01.2019 - 12.2019
Pharmacist Intern
Netcare Unitas
01.2018 - 12.2018
B.Pharm - Pharmacy
North West University
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