Paballo Mazvizvo
Johannesburg
Summary
Pharmacist and CQI/IRCA certified lead auditor with over 15 years of experience in sterile pharmaceutical manufacturing and quality assurance. Expertise in conducting risk-based audits, managing nonconformities, and ensuring regulatory compliance with SAHPRA, FDA, and GMP/GWP standards. Currently performing ISO 13485 and 9001 assessments while consulting on QMS implementation and delivering staff training on QMS processes and audit readiness. Seeking roles as an auditor and trainer to enhance quality management systems in the medical device and pharmaceutical industries.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Senior Production Pharmacist & Dispensary Pharmacist
Fresenius Kabi Manufacturing SA
01.2022 - 01.2024
- Managed sterile production processes, ensuring weekly targets were met while maintaining Grade A cleanroom compliance and performing line clearances/openings.
- Audited BMRs and resolved internal/release queries, applying QMS tools including change controls, deviations, and CAPA.
- Participated in internal/external audits and supported closure of production findings, strengthening overall QMS effectiveness.
- Conducting Stage 1 and Stage 2 audits (total 40+ audit days to date) as Auditor and Observer across medical device and pharmaceutical QMS.
- Applying ISO 19011 principles to plan, execute, and report audits, focusing on risk-based thinking, process effectiveness, and regulatory alignment.
- Identifying nonconformances in key areas including production controls, CAPA, documentation, and traceability; supporting corrective action implementation and verification of effectiveness.
Warehouse Pharmacist & Quality Assurance Pharmacist (Exports)
Aspen Pharmacare
01.2018 - 01.2021
- Managed pharmaceutical raw material receiving, dispensing, and warehouse operations under GMP/GWP, including environmental controls and temperature monitoring for exports.
- Raised and closed change controls/deviations; updated SOPs and delivered training to staff.
- Handled customer complaints, returned/expired stock, and participated in national/international audits (SAHPRA, FDA).
- Ensured proper disposition labelling, stock control, and destruction of rejected materials.
Production Pharmacist – Small Volume Parenterals (Sterile)
Aspen Pharmacare
01.2010 - 01.2011
- Operated in Grade A cleanroom sterile environment; completed and audited batch books.
- Supported media fills (Quality Control) and participated in internal/external audits.
- Updated SOPs and delivered staff training on sterile manufacturing processes.
Education
Bachelor of Pharmacy -
University of KwaZulu-Natal
01.2005
Skills
- ISO 13485:2016 & ISO 9001:2015 Lead Auditing (ISO 19011 principles)
- Risk-based auditing, process approach, and PDCA cycle
- Nonconformity identification, root cause analysis (5 Whys, Fishbone), CAPA management
- Change control, deviations, batch manufacturing records (BMR) auditing
- Sterile manufacturing controls (cleanroom Grade A, media fills, line clearance)
- Supplier/warehouse qualification, stock control, and distribution practices (GWP/GDP)
- Training needs analysis, course delivery, and competence evaluation (ISO 13485:2016)
- Customer complaint resolution
- Regulatory compliance: SAHPRA, FDA audits, GMP, Good Warehousing Practices
- QMS documentation: SOP creation/updates, management review support
- Microsoft Office (including Intermediate Excel)
- SAP
- QMS-Kabitrack
- DocCompliance
- ProcessCompliance
- Unisolve
Certification
- CQI and IRCA Certified ISO 13485:2016 Lead Auditor, BSI Training Academy, 2024-01-01
- CQI and IRCA Certified ISO 9001:2015 Lead Auditor, BSI Training Academy, 2024-01-01
- ISO 13485 Standard Requirements, Implementation & Internal Auditor Courses, JC Auditors Academy, Not Provided
- Facilitator Training (in progress), Execoach, Not Provided
- Bachelor of Pharmacy, University of KwaZulu-Natal, 2005-01-01
- Registered Pharmacist, South African Pharmacy Council, SAPC P24503, Not Provided
- Associate Member, International Register of Certified Auditors (IRCA), Not Provided
Languages
English (fluent)
Zulu
Afrikaans
Xhosa
Custom Section
ISO 13485:2016 & ISO 9001:2015 Assessor, JC Auditors, 2024-01-01, Present, Conducting Stage 1 and Stage 2 audits (total 40+ audit days to date) as Auditor and Observer across medical device and pharmaceutical QMS., Applying ISO 19011 principles to plan, execute, and report audits, focusing on risk-based thinking, process effectiveness, and regulatory alignment., Identifying nonconformities in key areas including production controls, CAPA, documentation, and traceability; supporting corrective action implementation and verification of effectiveness.
References
Available on request
Timeline
Senior Production Pharmacist & Dispensary Pharmacist
Fresenius Kabi Manufacturing SA
01.2022 - 01.2024
Warehouse Pharmacist & Quality Assurance Pharmacist (Exports)
Aspen Pharmacare
01.2018 - 01.2021
Production Pharmacist – Small Volume Parenterals (Sterile)
Aspen Pharmacare
01.2010 - 01.2011
Bachelor of Pharmacy -
University of KwaZulu-Natal