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The Pharmacy and Poisons Board is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya.
The Board regulates the Practice of Pharmacy and the Manufacture and Trade in drugs and poisons.
The Board aims to implement the appropriate regulatory measures to achieve the highest standards of safety, eff...
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Job Purpose
The position is responsible for the day-to-day regulatory activities of implementing standards, procedures, and guidelines to ensure the quality, safety, and efficacy of health products and technologies, and that pharmacy professionals are competent and fit to practice.
Duties and Responsibilities
- Receiving, screening, and undertaking dossier assessment, as well as reviewing variation and retention applications of health products and technologies.
- Receiving and screening applications for licensing of premises, as well as undertaking inspections of premises and medical products against good practices (GxP), laws, regulations, and guidelines.
- Receiving and investigating market complaints, conducting sampling of medical products, communicating, enforcing, and tracking regulatory actions.
- Receiving, screening, and reviewing of clinical trial applications, as well as inspecting clinical trial studies and sites.
- Collecting, analyzing, and monitoring safety reports, or any other reports on medical product-related problems.
- Receiving and processing applications for licensing of pharmacy practitioners and premises.
- Receiving, testing, and evaluating samples in adherence to established guidelines, standards, and procedures.
- Implementing the established Quality Management System (QMS) and benefit-risk strategy in regulatory decision-making regarding the regulation of health products, technologies, and pharmacy practice.
- Receiving and screening applications for lot release of vaccines and biologicals.
Person Specifications
For appointment to this grade, a candidate must:
- Have a Bachelor’s degree in Pharmacy from a recognized university.
- Have a valid practising license from the Pharmacy and Poisons Board, Kenya.
- Have a valid membership with the Pharmaceutical Society of Kenya.
- Be proficient in computer knowledge and skills.
- Have good analytical and communication skills.
- Fulfil the requirements of Chapter Six of the Constitution.
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Job Purpose:
The position is responsible for the day-to-day regulatory activities of implementing standards, procedures, and guidelines to ensure the quality, safety, and efficacy of biological and other pharmaceutical products through quality control testing.
Duties and Responsibilities:
Duties and responsibilities will entail:
- Implementing, and interpreting policies, rules, guidelines, standards and procedures for the laboratory testing and lot release of registered biological products in the Kenyan market
- Preparing and performing routine basic laboratory procedures and tests, as per specifications or work instructions
- Handling, labelling, and disposing of hazardous materials in accordance with the laboratory procedures for handling of reagents and chemicals
- Applying routine laboratory safety procedures, recognizing unsafe conditions and taking corrective or preventive action(s)
- Maintaining an inventory of raw materials, parts, components or equipment
- Coordinating receipt and testing of biological and pharmaceutical samples
- Sampling medicines during post-market surveillance, investigative sampling
- Participating in out-of-specification and failure investigations
- Maintaining chemical and equipment traceability records
- Maintaining laboratory environmental logs
- Documenting laboratory data and results according to established procedures
Person Specifications
For appointment to this grade, a candidate must:
Have a bachelor’s degree in any of the following disciplines:
- BSc Biotechnology
- BSc Biochemistry
- BSc Microbiology
- BSc Biomedical Sciences
- (from a recognized institution)
- Be a member of a relevant professional body and in good standing
- Be proficient in computer applications
- Fulfil the requirements of Chapter Six of the Constitution
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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
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Job Purpose
The position is responsible for protecting the organization’s information assets by implementing and managing security measures to safeguard data and systems. Works to prevent data breaches, cyberattacks, and other security incidents, ensuring the confidentiality, integrity, and availability of the company’s digital infrastructure. This role requires expertise in identifying vulnerabilities, deploying security tools, and ensuring compliance with industry regulations.
Duties and Responsibilities
- Conduct regular security assessments and vulnerability scans to identify and address potential risks in the organization’s IT environment
- Perform risk analysis and develop risk management strategies to protect sensitive data and digital infrastructure
- Develop and maintain threat models to anticipate security challenges and address them proactively
- Identify and analyze security gaps in systems, applications, and infrastructure
- Develop, implement, and enforce information security policies, procedures, and standards across the organization
- Establish and maintain access control policies and ensure that data is accessible only to authorized individuals
- Monitor systems, networks, and applications for signs of suspicious activity or potential threats using security monitoring tools
- Respond to security incidents (such as data breaches, malware infections, and denial-of-service attacks) including investigation, containment, and remediation
- Lead post-incident analysis and reporting to identify causes and mitigate future incidents
- Maintain and manage incident response protocols, and coordinate with internal teams and external agencies during incidents
- Implement and manage security technologies such as firewalls, antivirus software, IDS/IPS, encryption tools, and vulnerability management platforms
- Conduct regular updates and patches to security systems and software to protect against known vulnerabilities
- Design and deliver information security awareness training to employees, helping them identify potential threats like phishing, social engineering, and malware
- Create guidelines and resources for employees to follow security best practices, such as password policies, data encryption, and safe online behavior
- Ensure the organization’s compliance with legal and regulatory requirements related to data security and privacy
- Prepare reports for management on the organization’s security posture and compliance status
- Work closely with IT and development teams to design, build, and maintain secure IT infrastructure
- Participate in secure application development by reviewing code and providing guidance on secure coding practices
- Stay up to date with the latest security threats, vulnerabilities, and industry trends to continuously improve security strategies
Person Specifications
For appointment to this grade, a candidate must:
- Have a Bachelor’s degree in Computer Science or any IT-related field from a recognized institution
- Hold Certified Industry Accreditations or membership of recognized industry associations and bodies
- Be proficient in computer applications
- Have good analytical and communication skills
- Fulfil the requirements of Chapter Six of the Constitution
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Job Purpose
The position is responsible for providing support in policy and strategy formulation and execution, planning and performance management, monitoring and evaluation, project management, and budget forecasting for the realization of the Board’s vision.
Duties and Responsibilities
- Participating in formulation of strategic and economic plans and policies
- Implementing the Board’s development strategies, plans, policies and programmes
- Implementing the Board’s ethics and anti-corruption framework
- Collecting data on the Board’s programmes, activities and projects
- Compiling supporting documents for performance reporting
- Implementing strategies for improvement of performance
- Participating in the monitoring and evaluation of Board’s performance
- Preparing and presenting statistical data in the form of survey reports and bulletins
- Developing and maintaining Monitoring and Evaluation (M&E) database
- Assisting in disseminating various M&E reports as requested
Person Specifications
For appointment to this grade, a candidate must:
- Have a Bachelor’s Degree in any of the following disciplines: Economics, Statistics, Business, Quality Assurance, or equivalent qualification from a recognized institution
- Be a member of a relevant professional body, where applicable
- Be proficient in computer applications
- Fulfil the requirements of Chapter Six of the Constitution
go to method of application »
Job Purpose
The position is responsible for the day-to-day regulatory activities of implementing standards, procedures, and guidelines to ensure the quality, safety, and efficacy of health products and technologies, and that pharmacy professionals are competent and fit to practice.
Duties and Responsibilities
- Support implementation of guidelines, standards, infrastructure, procedures, and tools for medical devices
- Support implementation of quality management systems and risk-benefit strategies regarding quality systems requirements for medical devices, risk management principles, and ISO 13485 standards
- Compile a list of Medical Devices and In-Vitro Diagnostics recommended for granting, withdrawal, suspension, renewal, and revocation of marketing authorization
- Maintain a register of all authorized Medical Devices and In-Vitro Diagnostics
- Participate in publishing lists of authorized or registered Medical Devices and In-Vitro Diagnostics with marketing authorizations
- Implement international guidelines, standards, and tools for post-market surveillance, risk management, advertising and promotional regulations, and supervision of reprocessing single-use medical devices
- Evaluate applications for marketing authorization of Medical Devices and In-Vitro Diagnostics supplied to the public
- Recommend the list of Medical Devices and In-Vitro Diagnostics approved for export
- Participate in capacity development programs related to evaluation, registration, retention, and renewal of Medical Devices and In-Vitro Diagnostics
Person Specifications
For appointment to this grade, a candidate must:
- Have a Bachelor’s Degree in Biomedical Engineering or other health science degree or its equivalent qualification from a recognized institution
- Experience in regulation of medical devices and In-Vitro Diagnostics will be an added advantage
- Hold a professional qualification and membership to a professional body, where applicable
- Be proficient in computer knowledge and skills
- Have good analytical and communication skills
- Fulfil the requirements of Chapter Six of the Constitution
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Job Purpose
The position is responsible for providing a wide range of advanced statistical expertise and support to the Pharmacy and Poisons Board in the collection, analysis, and interpretation of regulatory data and responds to a broad range of complex statistical issues arising from various operations of the PPB.
Duties and Responsibilities
- Designs, analyzes, implements, and reports findings on targeted statistical research studies; provides consultation to departments on experimental design and statistical research approaches, requirements, and scientific standards
- Works with departments to formalize analytics plans and reporting specifications; advises on statistical analysis strategies, reliability of measurements, identifiability of models, and presentation of results
- Assists in the preparation of research documents and reports
- Uses advanced statistical software, methods, and techniques to analyze and interpret research data; advises and assists in the development of inferences and conclusions
- Oversees and coordinates the work of statistical support staff, data entry staff, and/or students, as appropriate to the position
- Transfers data from paper formats into computer files or database systems using keyboards, data recorders, or optical scanners
- Creates spreadsheets with large numbers of figures without mistakes
- Verifies data by comparing it to source documents
- Updates existing data
- Retrieves data from the database or electronic files as requested
- Performs regular backups to ensure data preservation
Person Specifications
For appointment to this grade, a candidate must:
- Have a Bachelor’s degree in Biostatistics, Public Health, or any other relevant course from a recognized university
- Have a valid membership with the relevant professional body, where applicable
- Be proficient in computer applications
- Have good analytical and communication skills
- Fulfil the requirements of Chapter Six of the Constitution
go to method of application »
Job Purpose
The position is responsible for the day-to-day regulatory activities of implementing standards, procedures, and guidelines to ensure the quality, safety, and efficacy of health products and technologies, and that pharmacy professionals are competent and fit to practice.
Duties and Responsibilities
- Assisting in the development and updating of the internal audit manual
- Assisting in drafting specific audit assignment plans and programs
- Assisting in the coordination of preliminary reviews of the areas to be audited
- Assisting in ensuring sound systems, policies, and procedures for the effective functioning of the department
- Assisting in the implementation of quality management system
- Maintaining Internal Audit records and reports in compliance with best practices
- Assisting in verifying and analyzing periodical financial returns
- Assisting in the review of internal control systems
- Preparing systems and operational audit checklists
- Participating in the risk assessment process
- Assisting in updating risk registers
- Assisting in conducting systems audits
- Assisting in carrying out systems and operational audits as assigned
- Assisting in carrying out regular checks on systems, processes, and procedures
Person Specifications
For appointment to this grade, a candidate must:
- Have a Bachelor’s degree in any of the following disciplines: Commerce (Accounting/Finance Option), Business Administration (Accounting Option), or an equivalent qualification from a recognized institution
- Be a member of ICPAK or IIA
- Be proficient in computer applications
- Have good analytical and communication skills
- Fulfil the requirements of Chapter Six of the Constitution
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Job Purpose
The position is responsible for conducting system analysis, development, and encoding computer programs by entering computer code using the appropriate programming language. The role also involves performing routine maintenance and upgrades to keep systems current with changing technologies.
Duties and Responsibilities
- Confirms project requirements by reviewing program objectives, input data, and output requirements with analyst, supervisor, and client
- Arranges project requirements in programming sequence by analyzing requirements; preparing a workflow chart and diagram using knowledge of computer capabilities, subject matter, programming language, and logic
- Encodes project requirements by converting workflow information into computer language
- Programs the computer by entering coded information
- Confirms program operation by conducting tests; modifying program sequence and/or codes
- Prepares reference for users by writing operating instructions
- Maintains historical records by documenting program development and revisions
- Maintains client confidence and protects operations by keeping information confidential
- Ensures operation of equipment by following manufacturer’s instructions; troubleshooting malfunctions; calling for repairs; evaluating new equipment and techniques
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
- Contributes to team effort by accomplishing related results as needed
Person Specifications
For appointment to this grade, a candidate must:
- Have a Bachelor’s degree in Computer Science or any IT-related field from a recognized institution
- Hold Certified Industry Accreditations or membership of recognized industry associations and bodies
- Be proficient in computer applications
- Have good analytical and communication skills
- Fulfil the requirements of Chapter Six of the Constitution
Method of Application
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