MAMABOLO MAMONARE MELIDA
Johannesburg
Summary
Analytical Method Validation Chemical Lab Analyst with over 8 years of experience in Pharmaceutical GMP environments. Expertise in streamlining validation processes and utilizing quality tools such as TQM. Proficient in software applications including Trackwise and Empower 3, with advanced skills in Excel reporting. Focused on enhancing operational excellence and driving quality improvements within the industry.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Analytical Method Validation Chemical Analys
Aspen South African Operations
06.2023 - 11.2025
- Executing analytical method validations and evaluations on Serum Vaccines and other SVP products according to approved protocols.
- Conducted method transfers of analytical procedures across various manufacturing sites.
- Evaluated and validated analytical methods parameters, such as linearity, Accuracy, Precision, Limit of Detection and Quantification, and robustness.
- Compiled and prepared preliminary analytical method validation reports efficiently.
- Communicated data and technical inquiries with team leaders to resolve issues promptly.
- Utilized advanced Excel functions to enhance reporting insights.
- Streamlined workflows by diminishing project gaps and reducing task duplication.
Senior Laboratory Analyst
SunPharma (PTY) Ltd
03.2017 - 05.2023
- Executed independent quality control testing of stability samples according to MOA and SOPs.
- Evaluated laboratory results against specifications, conducting trend data analysis for compliance.
- Contributed to investigations regarding QC deviations, OOS/OOT and Lab Events and documenting findings in Trackwise electronic management system.
- Provided comprehensive support for audit preparations, recommending changes for compliance improvements.
- Updated laboratory standard operating procedures to reflect current industry standards.
- Led junior analysts through training initiatives to boost skill levels and productivity.
- Coordinated sample management from Stability Chambers, ensuring efficient workflow management.
- Reduced turnaround times for sample analysis by 15% through streamlined processes without sacrificing quality.
Junior Lab Analyst
PharmaSpec Consulting Laboratories
07.2014 - 02.2017
- Conducted quality control testing on routine, in-process, finished, and stability pharmaceutical samples.
- Performed quality control standards and assays using HPLC, AAS, FTIR, UV-VIS spectroscopy, and dissolution methods.
- Ensured adherence to specified protocols from third-party laboratories.
Intern
Council For Scientific & Industrial Research
04.2009 - 05.2010
- Conducted research on drug discovery, applying chemistry to identify bioactive natural products.
- Explored biosynthesis mechanisms of natural products to develop superior drugs across therapeutic areas.
- Executed formulation studies for antimalarial and analgesic drug development projects.
- Performed compound processing and structural elucidation using nuclear magnetic resonance and gas chromatography techniques.
Education
Certificate - Quality Assurance
Nelson Mandela University
Port Elizabeth, Eastern CapeB.Sc. degree - Chemistry and Biochemistry
University of Limpopo
Turfloop CampusGrade12 - Biological Sciences Stream
S J Van Der Merwe Technical High School
CapricornSkills
- Quality and Compliance: GMP, GLP, GDP, Risk Assessment, Method Validation, Stability Trend Analysis, Audit Preparation
- Quality Tools: TQM, Quality Design and improvement, Reliability, Control charts, Acceptance sampling, Problem Solving
- Technical Skills: Troubleshooting, HPLC (Waters and Shimadzu) GC, AAS, UV-VIS, Potentiometric titration, UV-VIS, Dissolution testing
- Leadership and guidance: Excel reporting expertise, Mentoring and supervision
- Software Proficiency: Trackwise (Deviations and CAPA Management), Empower 3 (Chromatography Data system)
Accomplishments
Award Recognition
Recognized and Nominated in the Woman Achievement Aspiration Award, Aspen, 2023
Standard Operating Procedure Enhancement
Implemented new SOPs, enhancing lab accuracy and efficiency by 25%.
Process Improvement Success
Streamlined processes, reducing analysis time by 15% while maintaining quality.
Effective Project Leadership
Led cross-functional team to complete 20 method validations within 6 months.
Certification
- Risk Based Thinking and Management
- Nonconformances, Root cause, Investigations, Corrections and Corrective Actions
- Performing an internal audit on ISO 15189:2022 Clause 8,5 8,6 8,7 8,8 & 8,9
Personal Information
EDUCATION
Current
REFERENCES
- Gareth Saunders, Team leader, Aspen SA Operations, 0725113399, 041-409 3288
- Olivia Seloro, Lab Supervisor, SunPharma Pharmaceuticals, +27815386812
- Jerry Senabe, Supervisors, Council for Scientific and Industrial Research, +27128414077
Timeline
Analytical Method Validation Chemical Analys
Aspen South African Operations
06.2023 - 11.2025
Senior Laboratory Analyst
SunPharma (PTY) Ltd
03.2017 - 05.2023
Junior Lab Analyst
PharmaSpec Consulting Laboratories
07.2014 - 02.2017
Intern
Council For Scientific & Industrial Research
04.2009 - 05.2010
B.Sc. degree - Chemistry and Biochemistry
University of Limpopo
Grade12 - Biological Sciences Stream
S J Van Der Merwe Technical High School
Certificate - Quality Assurance
Nelson Mandela University