Mamonare Melida Mamabolo
14287 Fountain Grass Ext13 Protea Glen Johannesburg
Summary
Results-driven Analytical Validation Chemist with over 8 years of experience in the pharmaceutical industry, specializing in analytical method validation, chemical analysis, and quality control in GMP-regulated environments. Holds a BSc in Chemistry and Biochemistry, complemented by advanced studies in Quality Assurance. Expertise includes Total Quality Management (TQM), Statistical Process Control, ISO Standards, and structured problem-solving methodologies. Proficient in operating advanced analytical instruments, ensuring data accuracy, supporting compliance efforts, and driving continuous improvement initiatives to maintain audit readiness. Committed to delivering high-quality scientific work while actively pursuing professional growth opportunities within the pharmaceutical sector.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Analytical Method Validation Chemical Analyst
Aspen South African Operations
Port Elizabeth
06.2023 - Current
- 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.
- Ensured version control of documents after completion of method validation, maintaining compliance and accuracy.
Senior Laboratory Analyst
SunPharma (PTY) Ltd
City of Johannesburg, Roodepoort
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 document management system.
- Provided comprehensive support for audit preparations, recommending change control ( CAPA) for compliance improvements.
- Updated laboratory standard operating procedures to reflect current industry standards.
- Led junior analysts through employee training initiatives to boost skill levels and productivity.
Junior Lab Analyst
PharmaSpec Consulting Laboratories
Johannesburg, Randburg
07.2014 - 02.2017
- Conducted quality control testing on routine, in-process, finished, and stability pharmaceutical samples by adhering to Quality control procedures.
- Performed quality control standards and assays using scientific instrumentation such as HPLC, AAS, FTIR, UV-VIS spectroscopy, and dissolution methods.
- Ensured adherence to specified protocols from third-party laboratories. and Health and safety practices
- Ensured effective equipment management and usage
Intern
Council For Scientific & Industrial Research
City of Tshwane
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.
- Performed compound processing and structural elucidation data interpretation using nuclear magnetic resonance and GC-Mass Spectrometer techniques.
- Delivered weekly research and project progress presentations to multidisciplinary scientific teams ensuring technical requirements and project milestones.
Education
Certificate - Quality Assurance
Nelson Mandela University
11.2025
B.Sc. degree - Chemistry and Biochemistry
University of Limpopo
05.2007
Grade12 -
S J Van Der Merwe Technical High School
12.2002
Skills
Quality and Compliance: ISO Standards 9001,15189, Good Laboratory Practice, Good Manufacturing Practice and Good Documentation Practices, Risk Assessment, Method Validation, Stability Trend Analysis, Audit Preparation
Quality Tools: TQM, Quality Design and improvement, Reliability, Control charts, Acceptance sampling, Problem Solving
Technical Experience: Troubleshooting on lab Equipment, HPLC GC, (Waters and Shimadzu) 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), Computer Literate ( Microsoft Word, Excel, Powerpoint)
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 and Equipment.
Project Contributions and Improvement
Played a key role in completing over 20 analytical method evaluation. validation and transfer projects within 6 months.
Certification
- Quality Assurance
- 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 and 8,9
Additional Information
Strength
- Good Communication
- Attention to detail
- Good Presentation Skills
- Good interpersonal skills
Timeline
Analytical Method Validation Chemical Analyst
Aspen South African Operations
06.2023 - Current
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
Certificate - Quality Assurance
Nelson Mandela University
B.Sc. degree - Chemistry and Biochemistry
University of Limpopo
Grade12 -
S J Van Der Merwe Technical High School