Nokuthula Elizabeth Tshabalala
Summary
Detail-oriented and proactive Pharmacist with extensive experience in Quality Assurance within sterile pharmaceutical manufacturing. Proven track record in ensuring regulatory compliance (cGMP, SAHPRA, WHO, PIC/s), executing batch releases, handling product complaints, and supporting site audit readiness. Adept at using SAP, LIMS, and Veeva QDocs. Currently serving as a QA Release Pharmacist at Biovac, delivering on-time, compliant product releases while driving continuous improvement. Valued for critical thinking, cross-functional collaboration, and a quality-first mindset.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Quality Assurance Release Pharmacist
Biovac
09.2024 - Current
- Ensure the QA Release section aligns with Biovac's pharmaceutical quality system, GMP, SAHPRA, WHO, and PIC/s standards.
- Review and approve batch manufacturing records, QC documents, and full batch release packages across various departments (Formulation, Filling, Packaging).
- Release finished products within defined timelines, ensuring full compliance with marketing authorizations and quality specifications.
- Lead the Lot Release application process: complete, upload, and follow through to approval by regulatory authorities.
- Evaluate and authorize product/material reprocessing, ensuring compliance with validated processes.
- Support the Responsible Pharmacist and Head of Quality in investigations (e.g., product recalls, deviations, adverse events).
- Handle product quality complaints, perform root cause analysis, and ensure timely closure of CAPAs.
- Compile and review Annual Product Quality Reviews and ensure alignment with continuous improvement goals.
- Participate in planning, risk mitigation, and strategy alignment for QA-related deliverables.
- Act as QA representative in cross-functional meetings to provide quality input on production, supply chain, and validation.
- Monitor and report quality KPIs, investigate trends, and implement quality-driven improvements.
- Ensure strict control and legal compliance for the handling and documentation of scheduled substances.
- Contribute to the development of departmental SOPs, ensuring relevance, clarity, and regulatory alignment.
- Support site audit readiness by ensuring timely resolution of audit findings and proactive GMP compliance.
- Provide ongoing coaching, training, and mentorship to QA team members and cross-functional staff.
- Participate in succession planning and capacity/resource management for departmental continuity.
- Represent QA in site-wide initiatives, process improvements, and business optimization projects.
- Liaise with local and international regulatory authorities, service providers, and third-party partners.
Quality Assurance Release Pharmacist
Aspen Pharma
01.2022 - 08.2024
- Company Overview: SVP
- Reviewed batch documentation and production conditions to assess compliance with quality procedures, standards, and product specifications.
- Reviewed and approved quality of new, in-process, and released batches to assess compliance with quality control programs, product specifications, and GMP guidelines.
- Approved and released production batches within timelines aligned with OTIF and planning schedules.
- Determined disposition of in-process and finished products for clinical and commercial use.
- Ensured changes and deviations in production or quality control were approved in accordance with the QMS.
- Monitored and audited compliance with regulatory and internal standards for cGMP.
- Investigated systematic quality problems and developed preventative plans in collaboration with production teams.
- Contributed input into GMP-related training needs and supported readiness for internal and external audits.
- SVP
Quality Assurance Manager & Deputy Responsible Pharmacist
Bennett Brothers CC
09.2020 - 01.2022
- Provided support by timely review and release of product batches.
- Managed quality complaints, investigations, and root cause analysis.
- Maintained accurate QA database and ensured alignment with compliance requirements.
- Oversaw timely QA release of stock and assessed laboratory requirements for new product analysis.
- Drafted and updated SOPs, managed product information files (PIF), and handled retention sample control.
- Oversaw approval of master and batch documentation.
- Delivered SOP training and QA orientation to manufacturing personnel.
Community Service Pharmacist
Stratford Community Health Care Clinic
01.2019 - 01.2020
- Dispensed medications accurately and counseled patients on healthcare and medications.
- Supervised pharmacy staff and deputized for the managing pharmacist.
- Handled work schedules, conducted cyclic counts, and addressed pharmacy-related issues.
- Provided training and coaching to pharmacist assistants.
Intern Pharmacist
Charlotte Maxeke Johannesburg Academic Hospital
01.2018 - 01.2019
- Dispensed and optimized medication use in hospital settings.
- Participated in antimicrobial stewardship and applied research findings.
- Managed storage, distribution, and compounding of pharmaceuticals under GMP.
- Ensured compliance with Section 21 medicine procedures.
Post-Basic Pharmacist Assistant (Locum)
Clicks Pharmacy
03.2017 - 11.2017
- Dispensed prescriptions, provided patient counseling, and assisted in inventory control.
- Compounded extemporaneous mixtures and processed repeat prescriptions.
MBS Tutor & Practical Demonstrator
University of the Western Cape
01.2013 - 12.2014
- Delivered tutorials, practical lessons, and lab demonstrations in Medical Bioscience.
- Guided student learning, facilitated consultations, and ensured lab safety.
Education
BPharm -
University of the Western Cape
01.2017
BSc - Medical Bioscience
University of the Western Cape
01.2012
Matric - undefined
Elite College
01.2009
Skills
- CGMP
- GDP
- GxP
- Deviation Management
- PIFs
- SAP
- LIMS
- Veeva QDocs
- Unisolve
- Leadership
- Critical Thinking
- Risk Management
- Time Management
- Audit Readiness
Certification
- Aseptic Processing & ATMPs, 03/01/24
- Contamination Control Strategy, 10/01/23
- GMP Training, 11/01/20
- GxP for Medicines & Medical Devices, 06/01/21
- PIF & RP Training, Cleanroom Forum (BASAN), 01/01/22
Languages
English
IsiZulu
Sesotho
Personal Information
- Registration: SAPC Reg: P46600
- Willing To Relocate
- Title: Pharmacist
Timeline
Quality Assurance Release Pharmacist
Biovac
09.2024 - Current
Quality Assurance Release Pharmacist
Aspen Pharma
01.2022 - 08.2024
Quality Assurance Manager & Deputy Responsible Pharmacist
Bennett Brothers CC
09.2020 - 01.2022
Community Service Pharmacist
Stratford Community Health Care Clinic
01.2019 - 01.2020
Intern Pharmacist
Charlotte Maxeke Johannesburg Academic Hospital
01.2018 - 01.2019
Post-Basic Pharmacist Assistant (Locum)
Clicks Pharmacy
03.2017 - 11.2017
MBS Tutor & Practical Demonstrator
University of the Western Cape
01.2013 - 12.2014
BSc - Medical Bioscience
University of the Western Cape
Matric - undefined
Elite College
BPharm -
University of the Western Cape
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