Melisha Poken

An adaptable and solutions-driven senior quality assurance and compliance expert with over 14 years experience in the pharmaceutical, cannabis, medical device, complementary medicines, cosmetics and FMCG manufacturing industries. Proven expertise in devising and implementing quality assurance strategies to enhance process and system compliance. Track record of consistently achieving business objectives and successful audits, through a commitment to excellence and continual improvement.

Passionate about mentoring, training, and promoting a culture of quality.

Areas of Expertise:

• Quality management systems • Vendor assessments • Change management • Data analysis and reporting • Training and development • Complaint investigations • GxP Guidelines: SAHPRA, PIC/S, ICH, TGA, WHO, EMA, MHRA, FDA
• Auditing and inspections • Supplier quality management • Risk management • Product quality reviews • Deviations and CAPAs • Validation and qualifications • Artwork review • ISO Standards: 9001, 13485, 17025,22716, 14001, 45001, 31000

Skills:

• Critical thinking • High emotional intelligence • Attention to detail • Adaptability
• Strategy and business acumen • Leadership and communication • Problem solving • Planning and project management • Tech savvy

Professional Development Certificates:

• Lean Six Sigma White and Yellow Belts | MF Treinamentos | 2025
• How to Use Risk Management Principles (ICH Q9) | Qualistery | 2023
• ISO 9001:2015 Transition Workshop | MLI Training | 2015
• Internal Auditor Training | IMS |2014
• ISO 9001:2008 | Cape Peninsula University of Technology | 2012
• Total Quality Management (TQM) | University of South Africa | 2010

Education:

BSc Biological Science | University of KwaZulu-Natal | 2001- 2005

• Distinction awarded for final year research project, which was subsequently presented by the university atthe 8th International Workshop on Seeds, in Australia, May 2005.