Experience

LINK - A Clinigen company

• Singapore
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Manager - APAC

  • May 2021 - Present

  Overseeing and supporting the APAC affiliates in all matters related to Quality Management Systems, Quality assurance, Quality and Technical aspects of pharmaceutical wholesale and distribution, new product development/introduction, managing quality needs in final product release and supporting compliance efforts related to GxP regulatory requirements. Extensive knowledge in ISO 9001:2015 and ISO 13485 (Medical Devices), EU GDP, GMP and PIC/s. Designing and implementing Vendor Management procedures, including risk-based approaches and re-evaluation of suppliers.

• Quality Assurance Manager

  • May 2020 - May 2021



Clinigen South Africa, ZA

• Group Quality Manager

  • Mar 2018 - Apr 2020

  • Coordinating and supervising activities required to meet quality standards and ISO 13485, cGMP, GDP and PIC requirements including supervising, coaching, training and mentoring personnel • Implementing and overseeing appropriate quality management systems (QMS), preparing medical device business units for ISO 13485 accreditation • Planning, establishing and controlling risk management program related to quality system elements • Identifying training needs and organising training interventions to meet quality standards • Monitoring and reporting on QMS performance, producing data and measuring quality operations against set standards • Advising on changes and providing recommendations on change implementation • Providing training, tools and techniques to enable the achievement of quality standards • Producing various reports, presentations, analyses, correspondence and other quality documentation • Conducting inspections and performing GMP and GDP audits • Supervising vendor-supplied finished goods, maintaining effective compliance and corrective action procedures • Establishing quality requirements for external suppliers • Overseeing product and medical device recalls and withdrawals • Performing as a strong member of a cohesive team with strict adherence to health, safety and statutory regulations, quality standards, governance processes and compliance requirements



Eurolab Aseptic Services Unit, ZA

• Responsible Pharmacist / Quality Assurance Manager

  • Apr 2015 - Feb 2018

  • Coordinating and supervising activities required to meet quality standards and ISO 13485, cGMP, GDP and PIC requirements including supervising, coaching, training and mentoring personnel • Implementing and overseeing appropriate quality management systems (QMS), preparing medical device business units for ISO 13485 accreditation • Planning, establishing and controlling risk management program related to quality system elements • Identifying training needs and organising training interventions to meet quality standards • Monitoring and reporting on QMS performance, producing data and measuring quality operations against set standards • Performing Pharmaceutical facility, process and equipment validation and qualification • Advising on changes and providing recommendations on change implementation • Providing training, tools and techniques to enable the achievement of quality standards • Producing various reports, presentations, analyses, correspondence and other quality documentation • Conducting inspections and performing GMP and GDP audits • Supervising vendor-supplied finished goods, maintaining effective compliance and corrective action procedures • Establishing quality requirements for external suppliers • Overseeing product and medical device recalls and withdrawals • Performing as a strong member of a cohesive team with strict adherence to health, safety and statutory regulations, quality standards, governance processes and compliance requirements



Fresenius Kabi South Africa, ZA

• Quality Assurance and Systems Pharmacist

  • Dec 2012 - Mar 2015



Medipost Courier Pharmacy / West Rand Regional Pharmacy, ZA

• Dispensing Pharmacist / Community Pharmacist

  • Jan 2011 - Nov 2012

  • Dispensing and distributing medications • Data entry, capturing patient scripts and managing databases • Cold chain management and implementing cold chain procedures • Dispensing and distributing medications • Data entry, capturing patient scripts and managing databases • Cold chain management and implementing cold chain procedures



West Rand Regional Pharmacy

• Pharmacist (CSP)

  • Jan 2011 - Dec 2011