Alice Mutambuki Mwongela
Ikutha
Summary
Dedicated Quality Assurance specialist with more than five years of working experience in Quality Systems. I have a proven ability to adapt to new environments and bring fresh ideas. I am dedicated to ensuring high-quality products and manufacturing processes by identifying gaps and delivering effective, quality solutions. I am a diligent worker, with an interest in expanding my knowledge and learning new ideas in Quality Assurance processes. I have a proven track record of timely work completion and process optimization. Strong data analysis skills and expertise in Microsoft Word, Microsoft Excel, and PowerPoint presentations. Practical time management skills, combined with strong leadership abilities, make me well-suited to join my next team. I possess a strong work ethic, and my core virtues include honesty, transparency, quality, and integrity. I aspire to work at a senior management level in the Quality Assurance sector.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Assurance Supervisor
Regal Pharmaceutical Limited
06.2024 - Current
- Review Quality Assurance standard operation procedures (SOPs).
- Responsible for preparing Quality System Review (QSR) reports and presenting them in the management review meetings.
- Responsible for checking all batch manufacturing and packing documents before final batch release.
- Responsible for managing loading for both local and export batches.
- Responsible for updating and ensuring Validation Master Plan (VMP), Cleaning Validation Master Plan (CVMP) equipment and utility qualification are executed.
- Adhere and comply to all; cGMP and cGDocP and data integrity standards.
- Responsible for performing and managing Root Cause Analysis (RCA), Risk Assessment and Corrective and preventive Action (CAPA).
- Responsible for assessing employees training needs, scheduling and performing GMP trainings to foster a culture of compliance to standards on quality especially WHO.
- Review procedures/protocols and reports templates for process validation and cleaning validation.
- Conducting Self Inspection, Vendor Evaluation and Qualification, participating in regulatory bodies audit.
- Managing issuance, approval, implementation and closure of deviations.
- Supervision of the archiving Quality Management Documentation and Batch Release paperwork to ensure compliance with Company Policies as well as regulatory guidelines.
- Supervision of Quality Assurance Assistants and In Process Quality Assurance team.
Quality Assurance Officer
Tasa Pharma Limited
05.2021 - 05.2024
- Prepare and review Quality Assurance standard operation procedures (SOPs).
- Responsible for updating Validation Master Plan (VMP) and Cleaning Validation Master Plan (CVMP).
- Adhere and comply to all; cGMP and cGDocP record and integrity data standards.
- Equipment and utility Qualification.
- Perform Root Cause Analysis (RCA).
- GMP trainer to foster a culture of compliance to standards on quality especially WHO.
- Design procedures/protocols and reports templates for process validation and cleaning validation.
- Responsible for coordinating QMS related issues to ensure proper risk assessment and tracking.
- Follow up on implementation of proposed Corrective and Preventive Actions (CAPA) to ensure compliance.
- Conduct risk assessments for non-conformances.
- Participate in CAPA reply during external audits.
- Conducting Self Inspection and Vendor Evaluation and Qualification.
- Management of the archiving Quality Management Documentation and Batch Release paperwork to ensure compliance with Company Policies as well as regulatory guidelines.
- Ensure collection of validation samples and follow-up with Quality with Quality Control department to ensure analysis is done on timely manner and prepare the validation reports.
- Assessing employee training needs.
- Designation and Monitoring of Storage Conditions for raw materials, packing materials and finished products.
- Performing In-process Checks.
Industrial Attachment Quality Assurance Department
Mombasa Cement Limited
04.2019 - 07.2019
- Assisted in ensuring excellence of the final cement product by sample collection, sample preparation such as size reduction and analysis to ensure the mineralogical and chemical composition of raw materials met the set standards as well as doing both physical and chemical tests on the finished product to ensure quality of the same.
- Introduced to identification of deviations from target quality standards and rectification of the same.
Education
Bachelor of Science. - Industrial Chemistry with Management
Kenyatta University
01.2019
High School -
Loreto High School
Limuru01.2014
Primary School -
KYANDULA PRIMARY SCHOOL
01.2010
Skills
- Attention to detail
- Problem solving
- Team leadership and cross-functional teamwork
- Statistical analysis
- Critical thinking
- Leadership
- Effective communication
- Training and mentoring
Accomplishments
- Former youth chairlady at Kenya Assemblies of God-Fedha Church
- Awarded certificate of best in humanities at Loreto High School Limuru 2014.
- Awarded certificate of best in business studies Loreto High School Limuru 2013 and 2014.
- Awarded certificate of best team volunteer services Pacemaker International.
Referees
- Michele Omondi, Quality Assurance Manager, Regal Pharmaceuticals Ltd., 0708871631
- Polinary Okoth, Quality Assurance Supervisor, Tasa Pharma Ltd., 0714836045
- David Maingi, In charge of Quality Assurance, Mombasa Cement Ltd., 0727676998
- Rev. Alex Titus, Youth Pastor, Kenya Assemblies of God - Fedha Church, 0716015013
Affiliations
I enjoy camping and exploring new places. When I am alone, I find pleasure in reading books and listening to worship songs.
Certification
- Occupational Health and Safety Awareness Training - Envirolink Consultants Ltd.
- Leadership Management & Mentorship - Kenyatta University.
- First Aid Awareness Training - Envirolink Consultants Ltd.
- Fire Safety Awareness Training - Safe Tech International.
Timeline
Quality Assurance Supervisor
Regal Pharmaceutical Limited
06.2024 - Current
Quality Assurance Officer
Tasa Pharma Limited
05.2021 - 05.2024
Industrial Attachment Quality Assurance Department
Mombasa Cement Limited
04.2019 - 07.2019
Bachelor of Science. - Industrial Chemistry with Management
Kenyatta University
High School -
Loreto High School
Primary School -
KYANDULA PRIMARY SCHOOL
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