Duncan Onyango Email & Phone Number

Ensuring the general compliance of the QMS in the company. Propose new improvement to the company.Ensure complete implementation of changes and effective monitoring.

Nairobi, Kenya

• Playing Administrative role in the management of Quality Assurance Department• Review and monitoring QMS tools including change control requests, deviations, out of specifications, corrective and preventive actions (CAPA)• Handling and investigating Market Complains and monitoring reports for Root course and corrective and preventive measures.• Liaise closely with other departments i.e. Production, Warehouse Quality Control, Engineering and procedure to ensure GMP aspects are strictly observed in conducting all the processes. • Monitoring production and quality control operations are clearly specified in a written form as SOPs as GMP and GLP requirements are adopted• Help in conducting all audits; Internal and External Audits including supplier audits.• Review of executed Batch Manufacturing Records and Ensuring timely release of Finished Pharmaceutical Product for sale to the Market.• Ensure training of all personnel on Quality Assurance Aspects and GMP.• Ensure that the products are designed and developed in a way that takes account the requirements of cGMP and Good Laboratory Practice.• Ensure that critical steps of manufacturing processes and significant changes to these processes are validated• Ensure adherence to the procedure for self-inspection and quality audit that are used to appraise the effectiveness and continued applicability of the QA system.• To oversee Process, cleaning, Analytical and Microbial Method validation• Ensure all machines and equipment are qualified/ validated.• Following up of Regulatory and Registration Queries• Preparation of periodic Quality Systems Review reports.• Offer leadership/ mentorship and supervisory role in the Departments

Nairobi, Kenya

1. Microbiological analysis of drugs and medical devices including- Microbiological assays of Antibiotics and antifungals,- Sterility testing- Microbiological examination of non-sterile drugs and drug products- Bacterial Endotoxin testing - Chromo - LAL tets- Preservative efficacy test2. Carrying out media viability on all Microbiology media received and in use.3. Responsible for storage, handling and sub-culturing of standard Microorganisms.4. Offering training to students on attachment, Interns, new employees and other institutions.5. Preparing and reviewing of Standard operating procedures.6. Ensuring all Quality control records are updated and well maintained.7.;Calibration/Validation/ Performance check of equipment; Autoclave (Touchclave Lab), 4 Glove Isolator, Biosafety cabinets and Micro-plate Reader(BioTek LAL Reader)8. Any other duty assigned by my supervisor among other duties

Nairobi, Kenya

Busia

Microbiological examination of patient samples in the microbiology Laboratory

Iso 9001 Qms Internal Auditor

Bachelor Of Science - Bs, Microbiology, General, 2.1 (2Nd Class Honours Upper Division)

Kenya Certificate Of Secondary Education, B +