Quality Assurance Officer at Dorbe-Leit Solutions Limited

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:

• 4 in-house production units

key regulators: Pest Control Products Board, NEMA, KEBS, DOHSS

• PHARMACY and POISONS BOARD.
• VMD
• DVS
• KEPHIS
• Out-sourced quality control services
• Both local and overseas suppliers.

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.

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