Biotechnologists Specialists - 10 Posts at Pharmacy and Poisons Board

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