Role Overview
You will be responsible for keeping pharmaceutical production running reliably and safely, working directly on the manufacturing floor to ensure every batch meets strict quality standards before it leaves the facility. Your attention to process control and equipment performance directly protects patient safety and helps the company maintain its licence to operate with Kenya's Pharmacy and Poisons Board. On a typical day, you will move between production lines, line clearance checks, and documentation reviews, acting as the technical link between operators, quality assurance, and maintenance teams.
Key Responsibilities
- Oversee daily production activities for solid and liquid dosage forms, verifying that all process parameters stay within validated ranges and that batch documentation is completed accurately and legibly in real time.
- Perform line clearance and pre-production inspections to ensure no cross-contamination, correct material identification, and full compliance with WHO GMP and PPB Kenya requirements.
- Support equipment qualification, calibration, and preventative maintenance planning, reporting any deviations that could affect product quality and working with maintenance staff to resolve issues quickly.
- Write, review, and update standard operating procedures (SOPs), batch manufacturing records, and cleaning validation protocols to reflect current operational practice and regulatory expectations.
- Investigate process deviations, production complaints, and non-conformances, using root-cause analysis to propose and implement effective corrective and preventive actions.
- Train production operators on proper manufacturing techniques, GMP hygiene practices, and accurate documentation, reinforcing a culture of quality and compliance on the floor.
- Participate in internal audits and regulatory inspections by the Pharmacy and Poisons Board, preparing documentation and demonstrating that production processes are in full control at all times.
- Collaborate with the quality control laboratory on in-process and finished product sampling, ensuring that samples are taken correctly, at the right time, and delivered without compromising integrity.
Requirements & Qualifications
- Diploma in Pharmaceutical Manufacturing Technology, Mechanical Engineering, Industrial Engineering, or a related technical/scientific field; additional certifications in GMP or quality assurance are an advantage.
- Minimum of five years working in a pharmaceutical manufacturing environment, with hands-on experience in granulation, compression, coating, filling, or packaging operations.
- Demonstrated working knowledge of WHO Good Manufacturing Practices (GMP) and Pharmacy and Poisons Board (PPB) Kenya regulatory requirements, including documentation, traceability, and validation principles.
- Strong practical documentation skills, including the ability to maintain accurate batch records, deviation reports, and change control forms in a busy production environment.
- Good verbal and written communication skills in English, with the ability to give clear instructions to machine operators and report clearly to production and QA management.
- Proven teamwork and interpersonal skills, comfortable working closely with packaging, engineering, and quality departments to meet daily production targets without compromising compliance.
- Demonstrated problem-solving aptitude, particularly in identifying causes of process variation or equipment malfunction and recommending practical, sustainable fixes.
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