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Email Verified DAVID WACHIRA
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Member since November 15, 2023
Profile health 80%

Pharmaceutical Quality control $ Quality Assurance Expert

David is an Experienced Quality Control and Quality Assurance Analyst with over 8 years of working in commercial  and manufacturing quality control laboratories and in in-process quality assurance in pharmaceutical industries.

David is highly skilled in Laboratory analysis, Analytical Skills, Batch Processing, Process and cleaning validations, Document Management, Decision-Making, and pharmaceutical cGMP and cGLP.

David is certified in ISO 17025:2017, ISO 9001:2015, Internal audits, Hazard recognition, Management of employees among other courses.

Experience

Pharmaceutical Lab Head

  •  Hope Labs Group Ltd, Somalia
  •  Jul 2021 - Present

Drafting of ISO17025:2017 documents.
Implementation of GLP as per WHO guidelines and ISO 17025 requirements.
Responsible for receipt of analysis samples in the laboratory.
Validation and verification of analytical methods.
Verification and approval of analysis raw data and reports.
Ensure all the test items received in the laboratory are uniquely and unambiguously
identified.
Preparation of appropriate standard operation procedures.
Maintenance of the laboratory stock registers for the equipment and consumables.
Training and evaluation of laboratory personnel to develop competency.
Clean, maintain and keep records of equipment and apparatus as guided by the quality
manual.
Clean, maintain and keep records of equipment and apparatus as guided by the quality
manual.
Ensuring that the tests are performed to acceptable timescales and to the required
quality standards
Participate in internal and third party audits and implement resultant corrective,
preventive and improvement actions.

Snr Quality Control Analyst

  •  Dinlas Pharma Epz
  •  Jun 2019 - Sep 2023

Sampling of all received starting materials in consultation with warehouse manager.
Carrying out physical/chemical tests on raw materials, intermediate, finished products and stability studies products.
Handling, operating and calibrating sophisticated instruments like HPLC, UV, IR Spectrophotometer, and other QC instruments.
Ensuring that approved and rejected records of starting materials are maintained properly.
Preparation of Standard Testing Procedures (STPs).
Carrying out analytical method validations, process validation and cleaning validation.
Reporting and investigating Out Of Trend (OOT) and Out of Specification (OOS).
Reporting any accident or injury that arises in the course or in connection with my work.

Quality Control Analyst

  •  Sphinx Pharmaceutical Ltd
  •  May 2017 - Jun 2019

Receiving, sampling and analysis of raw materials, packaging materials, intermediate and finished products.
Providing accurate information/analytical results leading to sound decisions on the approval or rejection of raw materials, packaging materials, intermediate, bulk or finished products.
Carrying out environmental controls and keeping records.
Preparation and standardization of reagents and volumetric solutions.
Implementing all the aspects of Quality control systems and associated documentations with regard to cGMP, cGLP and approved pharmacopoeias.

Quality Control Analyst

  •  Aug 2015 - Apr 2017

Was introduced to Quality Control work.

Education

BSc Analytical Chemistry

  •  Jomo Kenyatta University of Agriculture and Technology (JKUAT)
  •  May 2011 - Dec 2014