Biotechnologists Specialists – 10 Posts
Full time @The Pharmacy and Poisons Board posted 17 hours ago in Health Care Shortlist Email JobJob Detail
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Job ID 6773
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Offered Salary 1000
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Career Level Others
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Experience 2 Years
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Gender Both
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Industry Healthcare
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Qualifications Diploma/Degree/Masters
Job Description
Biotechnologists Specialists – 10 Posts
Job Purpose
The position is responsible for the day-to-day regulatory activities of implementing standards, procedures, and guidelines to ensure the implementation of Lot Release for vaccines and biotherapeutics registration.
Job Specification
Duties and Responsibilities
- Interpreting test data relative to established specifications, standards, and control limits, and making recommendations on appropriateness
- Ensuring all vendors have been qualified and adhere to vendor qualification and performance standards with the aim of optimal utilization of equipment
- Reviewing test data from contract laboratories and external calibration service providers to ensure accuracy and regulatory compliance
- Using statistical methods and applying business and economic data in decision-making
- Identifying patterns in data that may indicate the test system is operating outside of specifications and investigating and troubleshooting when certain patterns exist
- Establishing corrective and preventive actions and ensuring review and follow-up
- Executing and approving/closing-out of laboratory investigations
- Systematically reviewing all operational procedures to identify potential risks and sources of non-compliance and areas that require improvement
- Reviewing of lot summary protocols and recommending for approval of lot release certificate
- Conducting and documenting regular safety inspections
- Ensuring compliance with the organization’s and regulatory Health and Safety Policies
- Establishing a waste management programme addressing the disposal of all hazardous, biological, pharmaceutical, and chemical waste
- Ensuring that analytical reports comply with standards and regulations
- Ensuring that procedures are carried out carefully and accurately to eliminate errors, by checking that all details have been considered
- Verifying analytical reports produced by other analysts
- Verifying the comprehensiveness of the tests, as well as the integrity and compliance of supporting documents, and ensuring follow-up of abnormalities
- Developing, installing, and revising validation procedures and protocols
- Writing and reviewing technical reports or documentation, such as deviation reports, testing protocols, and trend analyses
- Coordinating and tracking projects
- Training project teams and reporting performance metrics to supervisors
- Developing, maintaining, and abiding by project timelines and resource plans, and working directly with other team members to ensure deliverables meet target deadlines
- Ensuring integration of quality control functions with other regulatory functions
- Understanding and utilizing good control and inventory standards
- Evaluating performance of analytical methods and procedures to determine how they might be optimized and/or improved
Person Specifications
For appointment to this grade, a candidate must:
- Have a Bachelor’s Degree in Pharmacy, Biotechnology, Biochemistry, Molecular Biology, Microbiology, Biomedical Engineering, or any other relevant and equivalent qualifications from a recognized institution
- Have at least Eight (8) years of relevant work experience, three (3) of which must have been in a supervisory role
- Holding a Master’s Degree leading to recognition as a Specialist in Biotechnology, Vaccinology, Biotherapeutics, Immunology, Pharmaceutical Innovation & Drug Development, Molecular Biology, Pharmacotherapy, or equivalent qualifications from a recognized institution will be an added advantage
- Have certified courses in Biologics Development and Manufacturing, Vaccines Manufacturing, or Blood & Blood Products
- Hold professional certification and membership with a relevant professional body, where applicable, and be in good standing
- Possess a certificate in a management course lasting not less than four (4) weeks from a recognized institution
- Be proficient in computer applications
- Have demonstrated merit and ability as reflected in work performance and results
- Fulfill the requirements of Chapter Six of the Constitution
Method of Application
Visit https://web.pharmacyboardkenya.org/careers/ for details and application. Applications must reach PPB on or before 14 October 2025 at 11:59 pm EAT.
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