PRODUCT REGISTRATION OFFICER - ELYS CHEMICAL INDUSTRIES LTD.
(2013-10)
Preparation of dossiers required for product registration
- To compile the information required for product registration dossiers.
- Submission of registration dossiers and follow up by the relevant authorities.
- Preparation of variation documents regarding any variations to a registered pharmaceutical product.
- Application of retention, renewals and re-registration of products in the market.
- Application for advertisements for registered products as required by the company.
- Application for cGMP inspections, both internal and external.
- To assist in preparation of documentation required for tenders and questionnaires.
- To assist in the preparation of the product quality review.
- To assist in product development of new products.
- To assist in preparation and implementation of QMS documents and procedures e.g., Change Controls, Deviations. Internal Inspections, Failure Investigation, Market Complaint, Out of Specifications (OOS), Out of Trend (OOT), Out of Limit (OOL), CAPA's etc
- To assist in other document preparation and Quality Assurance duties as may be required by Quality Assurance department.
- Training of Students on attachment on Quality Assurance Regulatory affairs and GMP aspects.
- To carry out any other duty assigned by the company.
GMP ADMINISTRATOR - MAC'S PHARMACEUTICALS LTD.
(2012-01 - 2013-10)
To ensure that GMP is adhered to in the company.
- Training workers on the current G.M.P requirements as regards personal hygiene, sanitation, production, documentation, packaging, material handling etc.
- Formulating G.M.P training schedules and time table so that each department or production line undergoes G.M.P training regularly.
- Documenting the subjects covered during G.M.P training and the names of participants.
- Preparing S.O.P.s for all the operations in the company including cleaning and disinfection of building and personnel facilities, cleaning and decontamination of equipments, setting of equipments, products recall, customer complaints, receipt of materials in the company, material dispensing, etc.
- Ensuring that all the S.O.P.s are hanged in their relevant positions in the factory for workers to read.
- Reviewing the BMR's, Specifications and S.O.P.s regularly and retrieving the old BMR's, Specifications and S.O.P.s to the superseded BMR, Specifications and S.O.P.s file respectively.
- Ensuring that current BMR's and S.O.P.s are maintained in the master BMR and S.O.P.s file
- Liasing with Quality Assurance Manager in performing periodic self-inspection to evaluate the company's compliance to Good Manufacturing Practices in all aspects of production, quality control, documentation, validation, etc.
- Liasing with National Regulatory Authorities and other external parties to come and perform training of senior staff and other specialized training for production, maintenance and Q.C. personnel.
- Ensuring that G.M.P requirements are implemented by all personnel in the factory.
- Monitoring of the G.M.P training performance to see if they are being implemented by the workers.
VOLUNTEER - MUKURU PROMOTION CENTER (St. Catherine's Social Office)
(2010-09 - 2010-12)
- Identify individuals and families in need of support
- Assess the needs, circumstances, and support systems of the individuals and families identified
- Work with clients to determine achievable, actionable goals and plans to meet them
- Intervene in crisis situations involving abuse, sicknesses mental health emergencies, or trauma
- Maintain client records, case files, and paperwork
- Provide and distribute food to the individuals and families in the slum areas.
- Make house visits and provide resources like healthcare and food assistance to those suffering from illnesses like cancer
- Develop and strengthen programs and services that benefit clients to enable them to be self-reliant
Radioisotope Laboratory Technician - KENYA MEDICAL RESEARCH INSTITUTE (KEMRI)
(2009-05 - 2009-08)
Radioisotope laboratory, which deals with Lymphatic filariasis.
- I was exposed to some research principals and diagnosis of Lymphatic filariasis.
- Laboratory procedures including Immunochromatographic tests (ICT), Polymerase Chain Reaction (PCR), Electrophoresis.
- Various methods of DNA extraction from Serum, Sputum, Urine and Mosquitoes.
Teacher - SHALOM HILL SECONDARY SCHOOL
(2008-05 - 2008-08)
- Teaching Form One and Two Chemistry and Biology.
- Helping with carrying out teacher's duties in the school.
- Assisting in training the students Volleyball
