Mmakgotso Mokgadi

Experienced Laboratory Manager and Compliance Specialist with over 18 years of experience in pharmaceutical quality control, analytical chemistry, stability testing, method validation, and GMP/GLP compliance within highly regulated pharmaceutical environments. Proven expertise in laboratory leadership, quality management systems (QMS), audit readiness, method transfers, SOP development, and troubleshooting analytical instrumentation including HPLC, UPLC, GC, UV, and AA systems. Experienced in FDA and WHO audit environments with strong knowledge of cGMP, CAPA, OOS, OOT, deviation management, laboratory compliance operations, and team leadership.

Laboratory Manager - SABLE

(2025-05)

• Lead technical and compliance operations within the laboratory environment.
• Manage QMS activities including CAPAs, deviations, OOS, OOT, and change controls.
• Ensure compliance with cGMP and cGLP standards.
• Oversee SOP development and laboratory administration.

Laboratory Supervisor - SABLE

(2023-03 - 2025-04)

• Oversaw compliance laboratory operations and testing activities.
• Managed laboratory compliance documentation and QMS processes.
• Supported analysts with troubleshooting and equipment maintenance.

Compliance Supervisor - Adcock Ingram

(2015-08 - 2023-02)

• Managed technical operations within the QC compliance laboratory.
• Led QMS activities including CAPA management, deviations, OOS, and OOT.
• Supported successful WHO and FDA audit activities.
• Coordinated analyst training and laboratory upgrade initiatives.

Stability Supervisor - Adcock Ingram

(2013-03 - 2015-07)

• Managed a team of stability analysts within the QC laboratory.
• Reviewed and approved analytical data and summary reports.
• Performed troubleshooting on HPLC, UPLC, GC, and UV systems.

Senior Analyst / Team Leader - Bureau Veritas

(2012-10 - 2013-02)

• Performed pharmaceutical product analysis using HPLC, GC, AA, and UV techniques.
• Managed OOS investigations and analytical troubleshooting.

BSc - Chemistry (Honours) - North-West University (2001-01 - 2002-01)

BSc - Chemistry - North-West University (1997-01 - 1999-01)

Certificate - Project Management - UKWAKHILE Training & Consulting (2020-01 - 2021-01)

Grade 12 - Matric - Thuto-ke-Matla Secondary School (1996-01 - 1996-01)