National Quality Control Laboratory (NQCL) Principal Pharmaceutical Analyst (Biologics & Biopharmaceutical) Jobs in Kenya
Job Summary
Lead pharmaceutical analysis activities for biologics and biopharmaceutical products while ensuring compliance with WHO Good Practices for Pharmaceutical Quality Control Laboratories, ISO 17025 standards and regulatory requirements.
Provide technical oversight in laboratory operations, quality management systems, safety compliance, analytical testing and continuous quality improvement initiatives.
Key Responsibilities
Initiate the development and review of procedures and guidelines related to sample management.
Maintain compliance with WHO Good Practices for Pharmaceutical Quality Control Laboratories and ISO 17025 standards.
Review environmental control systems and initiate corrective and preventive action plans where necessary.
Communicate laboratory safety measures and ensure availability of Safety Data Sheets (SDS) for hazardous chemicals.
Maintain data security, protection and traceability through the Laboratory Information Management System.
Support departmental performance management, including performance contracting and appraisal processes.
Participate in preparation of departmental work plans and ensure efficient laboratory operations.
Generate requisitions for approval and participate in budget and procurement planning activities.
Ensure proper disposal of samples, reagents and laboratory waste in accordance with approved procedures.
Perform routine and complex analytical procedures in accordance with Standard Operating Procedures (SOPs).
Participate in resolving client complaints related to technical laboratory matters.
Update and maintain records of reference materials, chemical reference substances, buffers and cultures.
Participate in qualification, troubleshooting, operation and preventive maintenance of analytical equipment.
Prepare standard volumetric solutions and laboratory reagents according to recognized procedures.
Analyze and record test data and prepare reports using charts, graphs and narrative summaries.
Supervise and provide technical guidance to technicians and laboratory assistants.
Analyze out-of-specification samples, radiopharmaceuticals and anticancer products.
Capture and update laboratory inventories for samples, reagents, microorganisms, solutions, equipment and research materials.
Participate in Laboratory Certificate Testing, Inter-Laboratory
Comparison (ILC) schemes and other quality assurance activities.
Undertake Continuous Professional Development (CPD) in compliance with regulatory requirements.
Qualifications
Bachelor’s Degree in Pharmacy, Environmental Health or an equivalent qualification from a recognized institution.
Certificate of Registration as a Pharmacist from the Pharmacy and Poisons Board.
Membership to a relevant professional body.
Management course lasting not less than four (4) weeks from a recognized institution.
Certificate in Occupational Safety and Health (OSH).
Proficiency in computer applications.
Experience
Minimum cumulative service period of nine (9) years of relevant work experience.
At least three (3) years of experience at the level of Senior Pharmaceutical Analyst or in a comparable position.
Key Competencies
Biologics and Biopharmaceutical Analysis.
Pharmaceutical Quality Control and Quality Assurance.
WHO Good Practices for Pharmaceutical Quality Control Laboratories.
ISO 17025 Quality Management Systems.
Laboratory Safety and Occupational Health Compliance.
Analytical Method Application and Validation.
Laboratory Information Management Systems (LIMS).
CAPA Management and Continuous Improvement.
Analytical Equipment Qualification and Maintenance.
Data Analysis, Reporting and Documentation.
Staff Supervision and Technical Mentorship.
Inventory and Sample Management.
How to apply
For more information and job application details, see; National Quality Control Laboratory (NQCL) Principal Pharmaceutical Analyst (Biologics & Biopharmaceutical) Jobs in Kenya
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