Summary
Overview
Work history
Education
Skills
References
Hobbies and Interests
Projects
Disclaimer
Timeline
Generic
ENOCK MAYENGO

ENOCK MAYENGO

Kampala,Uganda

Summary

A self-motivated and innovative gentleman with a positive and enthusiastic attitude to work. Equipped with wide knowledge on Pharmaceutical Quality System, Good Laboratory Practice, analytical, quality control and deep understanding of Current Good Manufacturing Practices. Dedicated in ensuring product quality and regulatory compliance within pharmaceutical industry. Proficient in implementing and maintaining quality management system. Spirited in team building possessing excellent interpersonal skills. An effective communicator able to pick up new skills and collaborate with others in an inventive and pragmatic approach towards task completion and tenacity in pursuit of a goal.

Overview

6
6
years of professional experience
17
17
years of post-secondary education

Work history

Team Lead- Validation and Technology Transfer

Quality Chemicals Industries Limited
Luzira, Uganda
08.2024 - Current
  • Developing and implementing validation strategies for manufacturing and packing processes, equipment and systems in accordance with regulatory requirements and approved procedures.
  • Preparing, review and maintenance of Validation Master Plan for all processes, systems, equipment and facilities.
  • Leading validation projects including process, product, equipment, cleaning, hold times and system validation from initiation, planning, execution to completion, and providing guidance during execution.
  • Conducting risk assessment to identify potential validation risks and developing mitigation strategies to address them ensuing product quality, patient safety and regulatory compliance.
  • Change control management of proposed changes to validated systems, processes and equipment, and their implementation.
  • Providing support for regulatory submission and inspection.
  • Compiling of dossier documents and submission to RA.
  • Continued update of validation activities in line with the current best practices and guidelines (WHO, ICH and EMEA).
  • Driving continuous improvement initiatives within the validation function.
  • Performing due diligence and technical assessment prior to on-boarding new products.
  • Preparation of feasibility, Master Batch Manufacturing Records, validation protocol and reports, and execution.
  • Oversee technology transfer activities.
  • Investigation and CAPA management.
  • Supporting method verification and validation.

Quality assurance officer

Cipla Quality Chemical Industries Limited
Luzira, Uganda
10.2023 - 08.2024
  • Enforced adherence to Current Good Manufacturing Practices (cGMP) in accordance with documented procedures and guidelines.
  • Batch documentation review and ensure testing of batches before dispatch from the manufacturing site.
  • Oversaw generation, approval and issuance of batch documentation to ensure compliance and accuracy.
  • Approval, rejection and obsolete of batch numbers, batch issue requests, Excess Material Consumption Memo, Excess Material Return Memo, Daily Production Reports and Online rejection Notes through SAP.
  • Conducted equipment calibration and performed maintenance on manufacturing equipment.
  • Continuous SOP review and improvements to align with current guidelines.
  • Ensuring area cleaning and line clearance during product change over, oversee overprinting/embossing proof checking, and manage controls related to manufacturing, packing, and stores equipment.
  • Examining manufacturing environment to minimize product contamination and ensure environmental controls are maintained in manufacturing areas.
  • Performing in-process checks during manufacturing and packing operations.
  • Performing of pack line inspections and finished product sampling.
  • SAP system operation and ensuring timely data entry and management.
  • Reviewing Audit trail and electronic records of GxP equipment.
  • Performed warehouse inspections.
  • Oversaw pest control at the premises and external warehouse.
  • Developed training modules to elevate staff competency in QA practices.
  • Log book review to ensure compliance with standard practices.

Quality Control microbiologist

Cipla Quality Chemical Industries Limited, Luzira
Luzira, Uganda
12.2022 - 10.2023
  • Executed implementation of established national and international standards, including ISO 17025 and WHO guidelines, in sample testing and data management
  • Fostering a culture of data integrity through maintaining of accurate and legible documentation of laboratory activity including sample preparation, test procedures, and deviations found during testing ensuring compliance with quality standards.
  • Reviewing raw data and test results prior to approval
  • Process monitoring and improvement through monitoring of manufacturing process to ensure they are performed under controlled conditions.
  • Risk identification and mitigation through monitoring and identification of quality related issues in the production process ensuring consistent product quality.
  • Product testing and analysis to ensure they meet predetermined specifications contributing to the overall quality of products.
  • Participated in validation of manufacturing processes and cleaning procedures to ensure their efficiency.
  • Regular instrument calibration/maintenance to meet regulatory compliance requirements and ensure accuracy and reliability of data.
  • Participated in performing root cause analysis to determine the underlying factors and collaborated with Cross Functional Teams to implement Corrective and Preventive Actions.
  • Participated in training of production staff on proper aseptic techniques, hygienic practices and contamination control measures.
  • Demonstrated skills in isolation and identification of in-house isolates, and maintenance of standard stock and working cultures.
  • Conducted microbial analysis of purified and potable water.
  • Exercised a working knowledge of LIMS.
  • Timely and effective preparation of media and reagents for use.
  • Performed hold time studies and stability studies.
  • Carried out testing of presterilized and depyrogenated items.
  • Timely completion and reporting of analytical test reports and trend analysis for compliance.
  • Management of inventory for critical consumables.

Student researcher

National Agricultural Research Laboratories, Kawanda
Kawanda, Uganda
05.2022 - 07.2022
  • Developed, conducted and completed my undergraduate research project.
  • Carried out DNA extraction, quality control and gel electrophoresis.
  • Carried out molecular characterization of transgenic and non-transgenic East African Highland Bananas using PCR assay.
  • Performed High Performance Liquid Chromatography protocol for carotenoid quantification in Bananas
  • Conducted biochemical analysis of genetically enhanced bananas.
  • Performed NanoDrop spectrophotometry to check purity and quality of DNA extracted from selected leaf samples.
  • Carried out equipment calibration and maintenance, stock and working reagents preparation.
  • Gained hands-on and operating knowledge of laboratory equipment such as; BIO RAD C1000 Touch thermal cycler, SYNGENE Bio-Imaging Gel Documentation system, NanoDrop2000c Spectrophotometer, BenchTop K freeze-dryer.
  • Reviewed and carried out data analysis.
  • Carried out review and writing of monthly summary reports to the project team leader.
  • Documented findings which added to literature and knowledge to the knowledge pool.

Laboratory interne

Kyambogo University
Kampala
01.2021 - 03.2021
  • Conducted bacteriological analysis of food samples
  • Performed routine sterilization of laboratory equipment
  • Carried out gram staining procedures and histological tissue preparation procedures.
  • Carried out extraction of phytochemicals from medicinal plants using solvent and Soxhlet extraction.
  • Conducted susceptibility tests of bacterial to crude plant extracts using agar well and disk diffusion methods.
  • Carried out insectary techniques such as collection and breeding of mosquito larvae and pupae.

Laboratory interne

Lancet Laboratories, International Hospital Kampala
Kampala
05.2019 - 07.2019
  • Participated in specimen collection, preparation, labeling and completion of request forms
  • Participated in sample reception and entering of laboratory test results in LIMS.
  • Performed rapid tests like, Fecal Occult Blood (FOB), Helicobacter Pylori Antigen and Antibody, Rota and Adenovirus tests.
  • Carried out gram staining and Ziehl Neelsen and modified Ziehl Neelsen assay.
  • Carried out micro and macro examination of urine and stool following doctor’s request.
  • Conducted sputum (TB), cerebral spinal fluid (CSF) and pleural fluid analysis.
  • Conducted syphilis (TPHA) and trichomonas vaginalis testing.
  • Conducted Human Chorionic Gonadotropin Vaxpert test (HCG), HIV testing using the INSTI HIV antibody kit, ALERE DETERMINE HIV-1 and HIV-2 kit.
  • Performed blood tests e.g., malaria testing, typhoid testing (Widal Biotec test), Hepatitis B testing (HBSAG Vaxpert), Brucella (Abortus), hemoglobin, sickle cell tests and ESR.
  • Performed blood film staining and examination.
  • CrAg Lateral Flow Assay (Cryptococcal Antigen) in diagnosis of cryptococcosis.
  • Carried out ABO blood typing.
  • Conducted clinical chemistry tests; Liver and Renal functional tests and lipid profile tests.

Education

Bachelor of Science - Technology-Biology

Kyambogo University
08.2018 - 12.2022

Uganda Advanced Certificate of Education - Biology, Chemistry, and Foods & Nutrition

St. Augustine’s College
01.2016 - 12.2017

Uganda Certificate of Education - undefined

St. Augustine’s College
01.2012 - 12.2015

Primary Leaving Examination -

All Saints Lweza Primary School
01.2005 - 12.2011

Skills

  • Effective oral and written communication
  • Expertise in lean techniques
  • Understanding of cGMP and GDP
  • Training and Development
  • Leadership & influence
  • Quality assurance controls
  • Equipment maintenance
  • Presentation skills
  • Computer aided design
  • Programming
  • Team collaboration
  • Microsoft Office Suite
  • Laboratory information management systems
  • SYNGENE Gel Doc software
  • C1000 Manager software
  • NanoDrop 2000c software
  • APIWEB
  • Agilent ChemStation
  • Mendeley reference manager
  • PAST statistical software
  • GraphPad Prism

References

  • Aarekh Kumar Jain, Deputy Manager Research and Development, Cipla Indore Madhya Pradesh, India., aarekhkumar.jain@cipla.com, +919669123067
  • Diana Nakato, Quality Assurance Manager, Quality Chemical Industries Limited, Luzira Uganda., dnakato@qcil.com, +256774019333
  • Walugembe, Joel, Lecturer, Kyambogo University. Research Assistant, National Agricultural Research Laboratories Kawanda., wjoel60@gmail.com, +256706200187

Hobbies and Interests

Teamwork and collaboration, Creative writing, Health and fitness, Music and Dance

Projects

  • Successful transfer and product launch of Abacavir 60mg, Dolutegravir Sodium 5mg and Lamivudine 30mg Dispersible tablets, Abacavir 600mg, Dolutegravir Sodium 50mg and Lamivudine 300mg tablets.
  • Validation and implementation of Increcy In-process check system.
  • Part of the Banana Biofortification team under the National Banana Research Program at National Agricultural Research Laboratories, Kawanda in collaboration with Queensland University of Technology which developed Provitamin A Biofortified East African Highland Bananas as a sustainable strategy to alleviate cases of vitamin A deficiency affecting low-income populations through use of biotechnology techniques., A conceptual design to provide data on the distribution of Provitamin A carotenoids in different bunch sections of genetically enhanced transgenic bananas. The study demonstrated that Provitamin A biofortified East African Highland Bananas could be produced as a potential nutritional food resource due to its high Provitamin A content. In addition, Provitamin A bananas were recommended to be consumed in hands supplementing the middle and bottom with top hands for poorer urban dwellers who purchase fingers instead of bunches for maximum benefit., Currently writing a manuscript for my undergraduate research “Distribution of Pro-Vitamin A Carotenoids in Different Sections of Genetically Enhanced East African Highland Banana Bunches”.

Disclaimer

I declare that the information provided in this CV is accurate and authorize the recipients thereof to undertake whatever reasonable and necessary inquiries in relation to the information in this CV. Signed

Enock Mayengo

Timeline

Team Lead- Validation and Technology Transfer

Quality Chemicals Industries Limited
08.2024 - Current

Quality assurance officer

Cipla Quality Chemical Industries Limited
10.2023 - 08.2024

Quality Control microbiologist

Cipla Quality Chemical Industries Limited, Luzira
12.2022 - 10.2023

Student researcher

National Agricultural Research Laboratories, Kawanda
05.2022 - 07.2022

Laboratory interne

Kyambogo University
01.2021 - 03.2021

Laboratory interne

Lancet Laboratories, International Hospital Kampala
05.2019 - 07.2019

Bachelor of Science - Technology-Biology

Kyambogo University
08.2018 - 12.2022

Uganda Advanced Certificate of Education - Biology, Chemistry, and Foods & Nutrition

St. Augustine’s College
01.2016 - 12.2017

Uganda Certificate of Education - undefined

St. Augustine’s College
01.2012 - 12.2015

Primary Leaving Examination -

All Saints Lweza Primary School
01.2005 - 12.2011
ENOCK MAYENGO