Anelisa Nqini

Experienced Quality Assurance and Regulatory Compliance professional with 9+ years in GMP-regulated pharmaceutical and FMCG environments. Expertise in audits, CAPA, SOPs, quality management systems and training, with strong knowledge of GMP, HACCP, ISO, and global standards. Proven ability to lead teams, strengthen quality systems, and drive continuous improvement.

Laboratory Analytical Scientist at Aspen SA Operations (2022-12 – 2025-11)

Led microbiology lab operations ensuring compliance with GMP, ICH GCP, and ISO standards.

• Conducted internal audits and supported regulatory inspections with zero critical findings.
• Implemented CAPA processes and led root cause investigations, reducing deviations by 14%.
• Oversaw SOP development, document control, and QMS compliance.
• Mentored junior staff and conducted training on aseptic techniques and quality procedures.
• Utilized Veeva for tracking CAPAs, deviations, and audit documentation.

Microbiologist at Aspen SA Operations (2021-04 – 2022-11)

• Performed microbiological testing of raw materials, WFI, and cleanroom environments.
• Supported audit readiness and maintained compliance with FDA and EU GMP standards.
• Improved testing workflows and reduced turnaround time through process optimization.

Laboratory Technician at Aspen SA Operations (2018-08 – 2021-03)

• Executed environmental and water monitoring programs in sterile manufacturing.
• Maintained documentation and compliance with GMP and safety standards.
• Acted as SHE representative, promoting safety and hygiene compliance.

Microbiologist at Fresenius Kabi Manufacturing SA (2016-08 – 2018-07)

• Led aseptic mentorship and GMP coaching programs across production teams.
• Reduced contamination incidents by 70% through training and SOP enforcement.
• Collaborated with QA and production teams to resolve non-conformances and support audits.

Laboratory Technician (Contract) at SAB Ibhayi Breweries (2015-04 – 2015-10)

• Performed aseptic sampling and microbiological testing at critical control points.
• Supported packaging and brewing quality control processes.

Postgraduate Diploma in Business Administration – University of Witwatersrand (2026)

Postgraduate Diploma in Business Management – MANCOSA (2024)

BSc Honours in Microbiology – Nelson Mandela Metropolitan University (2014)

BSc in Biochemistry & Microbiology – Nelson Mandela Metropolitan University (2013)