Maureen Wanjigo
Wexford,Ireland
Summary
Motivated quality assurance professional with expertise in analytical techniques and good manufacturing practices (GMP). Proficient in process validation and statistical analysis to ensure regulatory compliance. Experienced in laboratory data analysis and quality control protocols, emphasizing accuracy and adherence to guidelines. Committed to enhancing operational efficiency and advancing healthcare through meticulous quality control processes.
Overview
2
2
years of professional experience
5
5
years of post-secondary education
1
1
Certification
Work history
QC Analyst Stability and Validation
Servier Industries
Arklow, County Wicklow
2025.08 - Current
- Conducted sample removal from stability chambers, ensuring correct environmental conditions, chain‑of‑custody, and timely transfer for analysis.
- Logged and tracked all incoming samples through LIMS, maintaining full data integrity and compliance with GMP documentation standards.
- Prepared and processed samples for a wide range of analytical testing in accordance with validated methods and SOPs.
- Performed physical quality tests including Average Mass, Disintegration, Hardness, and Appearance assessments on solid‑dose products.
- Executed stability chamber space optimisation, reorganising storage layouts to accommodate new stability studies and improve workflow efficiency.
- Carried out Total Organic Carbon (TOC) analysis on microbiological and active rinse samples to support cleaning validation and environmental monitoring.
- Performed HPLC analysis for Content Uniformity and related assays, ensuring accurate quantification and compliance with regulatory specifications.
- Conducted Karl Fischer titration on active pharmaceutical ingredients and multiple sample types to determine moisture content with high precision.
- Reviewed regulatory quality analysis tables for multiple batches across different markets, ensuring accuracy, completeness, and alignment with global reporting requirements.
- Collaborated with cross‑functional teams to support method validation, stability study execution, and data review in a GMP‑regulated environment.
- Ensured strict adherence to GMP, GLP, and data integrity principles, contributing to successful audits and regulatory inspections.
Manufacturing Science & Technology API intern
Bristol Myers Squibb
Dublin, Ireland
2024.01 - 2024.09
- Led Active Pharmaceutical Ingredient (API) yield monitoring as part of BMS simplification program, driving process improvements and efficiency in pharmaceutical manufacturing.
- Played a key role in developing digital dashboard in Spotfire to monitor Active Pharmaceutical Ingredient (API) yield, improving data visualization and process efficiency.
- Streamlined data management by transforming complex MS Excel spreadsheets into simplified, user-friendly templates, improving data accessibility.
- Designed standardized templates applicable to various pharmaceutical products, ensuring consistency in reporting and documentation.
- Authored, reviewed, and issued technical documents, including memos, monitoring plans, and reports, aligning with regulatory requirements and industry best practices.
- Conducted Continuous Process Verification (CPV) data analysis using Minitab and Excel, applying statistical tools to optimize yield performance.
- Completed Root Cause Analysis training, strengthening problem-solving capabilities and contributing to process enhancements.
- Supported Artwork & Packaging department, creating structured templates for packaging components and ensuring accurate specifications.
- Managed technical drawing requests, coordinating documentation, review, and approval processes for pharmaceutical packaging and labelling.
Education
Leaving Certificate - High school
Creagh College
Gorey, Co. Wexford 2018.09 - 2020.06
B.Sc. - Pharmaceutical Science
Technological University Dublin
Tallaght, County Dublin 2021.09 - 2025.05
Skills
- Effective communication and teamwork
- Analytical and critical thinking
- Attention to detail
- Problem solving
- GMP and GLP compliance
- Interpersonal skills
- ISO 17025 and ISO 9001 knowledge
- Time management
- Performance optimization
- Hazardous waste management
- Calibration of measurement equipment
- HPLC operation and maintenance
- Stability testing
- Analytical testing
Affiliations
- Volunteering; ESB Science Blast man stand for BMS, and NIBRT Careers Fair, 'Careers in Biopharma' event Reading Learning new languages Painting
Accomplishments
- API Yield Monitoring project award in BMS (Top ten) 2024
- TUD Academic Achievement 2021
Languages
6,6
Certification
- Root Cause analysis training and certification 2024
- Inno-EUt+ Climate Entrepreneurship Training 2022
Languages
English
Fluent
References
References available upon request.
Timeline
QC Analyst Stability and Validation
Servier Industries
2025.08 - Current
Manufacturing Science & Technology API intern
Bristol Myers Squibb
2024.01 - 2024.09
B.Sc. - Pharmaceutical Science
Technological University Dublin
2021.09 - 2025.05
Leaving Certificate - High school
Creagh College
2018.09 - 2020.06