Lesley-Ann Jeftha

Experience

• 

  UWC, Department of Biotechnology, Biochemistry

  Sept 2007 - Jan 2008

  Research assistant

  DNA and protein extraction from apple scab infected leaves for apple breeding studies

• 

  Agricultural Research Council

  May 2011 - Apr 2013

  Researcher
• 

  Division of Human Genetics, University of Cape Town

  May 2013 - Oct 2014

  Scientific Officer
• 

  Kapa Biosystems

  Nov 2014 - now

  • Quality Assurance Specialist

    Aug 2015 - now

  • OEM/ Custom Manufacturing Scientist

    Nov 2014 - Jul 2015
• 

  Roche

  Aug 2015 - now

  • Operations Quality: Quality SME in the high-performance Tiger Team. Facilitate NC and CAPA root cause investigations, risk analyses and change management; reviewing validation protocols and reports.• Systems Quality: Lead/participate in internal audits, second and third party audits; review documentation for improvement and/or create documentation to close gaps. Monitoring and reporting on KPI's.• Training and staff development: Conduct quality centric onboarding training of new starters, site-wide training on new and updated processes; and develop e-Learning content. Creating digestable bites of quality concepts in an initiative called ON Quality. Mentoring/coaching colleagues as required.• Regulatory Affairs: Preparing and submitting applications to SAHPRA.• Software testing: Developing scripts for User Acceptance Testing and execution thereof. Show less Assist the business in maintaining ISO 13485 and ISO 9001 certification by: 1. Conducting internal audits to identify ISO compliance requirements.2. Writing procedures where gaps have been identified.3. Training of staff on new and revised procedures. 4. Conducting NCR and CAPA investigations.5. Participate in design change and document change reviews. 6. Monitoring and maintaining CAPA, NCR, and change management processes.7. Supplier Quality management. 8. Act as theQuality SME in the new product development process.9. Drafting quality management plans. Show less

  • Snr Quality Assurance Specialist

    May 2020 - now

  • Quality Assurance Specialist

    Aug 2015 - Apr 2020