Quality Assurance Officer

  • Full-time

Company Description

Our client is the market leader in the industry in Animal health. As more players have come into the market, product diversification is a priority. Poor economic environment (affected mainly by erratic weather conditions) has left farmers with low income and diversity and climate-smart solutions are needed.
As a result, the company is expanding into new product areas. Minimum cGMP standards are key to achieving product quality and obtaining regulatory approvals.
Product quality is a key strategic and marketing differentiator with regulatory approval being mandatory for all markets.
The company has a presence in Kenya, Uganda, Tanzania and Rwanda.

Job Description

The role is an integral role with key responsibilities across the following areas:
• To confirm that our Quality Assurance serves to meet current Good Manufacturing
Practice and Regulatory requirement.
• Adhere and comply with the cGMP, policies, procedures and statutory guidelines.
• Work with 50 products and the following stakeholders:
o 4 in-house production units
o 4 key regulators: Pest Control Products Board, NEMA, KEBS, DOHSS
o PHARMACY and POISONS BOARD.
o VMD
o DVS
o KEPHIS
o Out-sourced quality control services
o Both local and overseas suppliers.

2 Sampling and Inspection
 Timely sampling and inspection of raw materials, packaging materials,
intermediate, finished and bulk products and effluent in line with approved
procedures.
In-process Quality Control Checks
 Carrying out in-process quality control checks at various stages of production by
confirming and verifying that production processes are carried out in accordance
with written approved instructions. Making records at various stages of
production as outlined in BMRs and BPRs.
 Record the investigation findings for process every failure and give
recommendations.
Line Clearance
 Timely Checking and giving approval to start- up or continual of production
processes after carrying out verification and inspection of status of equipment,
room and personnel as per approved procedures.
Market Returns
 Receiving and physical evaluation of all finished products returned from the
market and submission of report to Quality Assurance Manager. Compiling a list
of all products returned from the market and forwarding to Quality Assurance
Manager for further evaluation.
Documentation
 Real-time recording of Raw &Packaging Materials and Finished Products check-
lists. On-time filling-in of QA, Production and Warehouse registers and logs as
per approved procedures. Writing of Packaging Materials specifications and
inspection procedures and forwarding for approval. Participating when called
upon writing of selected SOPs.
Risk Mitigation, Compliance & Audit
 Monitoring and confirming of CAPA implementation. Confirming real time
documentation of BMR, BPR, cleaning logs and temperature logs.

3 Reporting
 Recommending to Quality Assurance Manager to receive or reject incoming
materials at the warehouse based on the set standards.
 Giving or declining to give line clearance for start-up or continuation of production
process.
 Make technical decisions as delegated by Quality Assurance Manager or Head
of QA

Qualifications

Diploma in Pharmaceutical Science, Chemistry, Biochemistry and Microbiology.
 1 year experience working in Quality Assurance
 Excellent oral and written communication in English and Kiswahili
 Good decision making
 Possess analytical skills

Additional Information

1-year contract renewable
 Monthly Salary of Kshs. 26,500 gross, plus bonus of 45% monthly (paid
quarterly) with benefits.

How to apply: If you are interested in the position and have the skills and talents our
client is looking for, we would like to hear from you. Please make your application to
before the close of business on 19th January 2024 on our website: www.dorbe-leit.co.ke Only successful candidates will be contacted.