Principal, Product Quality Officer – Quality Control at The Kenya BioVax Institute

Job Purpose:

The Principal Quality Officer – Quality Control will be responsible for performing all in-process quality control activities to ensure that the quality of all product batches meet adopted pre-set local and international quality standards and requirements including  but not limited to standards outlined in World Health Organization Good Manufacturing Practices (WHO GMP); Pharmacy and Poisons Act (Cap 244), The Standards Act (Cap 496), Medical Laboratory Technicians and Technologists Act (Cap 253A) and Kenya Accreditation Service Act, 2019.

Requirements:

• At least six (6) years’ experience in the relevant field, two (2) of which have been in a supervisory role in public service or private sector;
• Masters degree in any of the following fields: Pharmacy, Life/ Biological Sciences (Chemistry, Biochemistry, Biomedical Sciences, Microbiology) or its equivalent from a recognized institution;
• Bachelors degree in any of the following field: Pharmacy, Life/ Biological Sciences (Chemistry, Biochemistry, Biomedical Sciences, Microbiology) or its equivalent from a recognized institution;
• Membership to a professional body where applicable;
• Certification in Quality Management, Risk Management or any other relevant field;
• Experience with preparation and execution of quality control filings, notifications, & technical files for approval;
• Management course lasting not less than four (4) weeks from a recognized institution;
• Proficiency in computer applications;
• Shown merit and ability as reflected in work performance and results; and
• Fulfilled the requirements of Chapter Six (6) of the Constitution.

Job Specification

Key Competencies and skills

• Knowledge of relevant legislation and regulations;
• Good writing and communication skills;
• Organizational skills including planning, monitoring and controlling;
• Interpersonal skills;
• Detail-oriented;
• Ability to work under pressure;
• Team building;
• Adaptability;
• Accountability;
• Decision making and problem-solving;
• Conflict management;
• Coaching and mentoring skills;
• Integrity; and
• Results-driven

Key Duties & Responsibilities

• Supervise the execution of product quality control activities in liaison with other relevant stakeholders;
• Oversee the implementation of measures for adequate identification and segregation of test samples to avoid mix-up and cross-contamination
• Oversee the preparation of detailed instructions for each test and analysis;
• Coach and mentor officers to ensure skill development and competency;
• Oversees the maintenance of the sections records and information relating to product quality control activities to ensure proper data handling;
• Promote and generate a strong quality culture within the Institution through effective collaboration with peers;
• Plan quality control activities to assure the quality of all products manufactured by the Institute;
• Act as Subject Matter Expert (SME) on product quality control matters for all products manufactured in the Institute and provide "solution-based" advice to development teams;
• Coordinate environmental monitoring and equipment validation as appropriate for evaluating the adequacy of the manufacturing conditions with relevant functional areas;
• Release or reject raw materials and intermediate products, if necessary;
• Release or reject packaging and labelling materials and the final containers in which drugs are to be placed;
• Release or reject each lot of finished preparation;
• Establish expiry dates on the basis of the validity period related to specified storage conditions;
• Establish and, when necessary, revise product quality control procedures and specifications; and
• Ascertain the examination of returned preparations to determine whether such preparations should be released, reprocessed or destroyed.
• Proactively partner with Quality Assurance and Research & Development, and other relevant functional areas to develop and maintain product specifications and analytical procedures;
• Implement policies, strategies, standards, procedures and guidelines and Quality Management Systems on product quality control;
• Liaise with production department in controlling of their process and products at every stage of manufacturing to meet the pre-established specifications through testing, auditing, and reporting;
• Sample, inspect and test as per specifications of raw materials, packaging materials, in-process/intermediate product, and final/finished product for release or rejection and documentation;
• Review and update the adequacy and relevance of specifications & analytical procedures in coordination with the quality assurance section;
• Perform the calibration and preventive maintenance of instruments and types of equipment as per schedule in collaboration with engineering and relevant functional areas;
• Maintain and update quality control records, control samples of raw material and finished products of each batch manufactured;
• Develop and execute measures aimed at reducing the proportion of scrap, waste, and spoilage during the production process;
• Maintain and update labelling procedure at all the stages and record;
• Control sample storage;
• Maintain test records as per standard procedures for raw materials, packing materials, in-process/intermediates, and finished products;
• Ensure product support services are provided satisfactorily after the products have been sold;
• Monitor and maintain up-to date knowledge on global product quality control intelligence, provide impact evaluation to changing regulations and mitigation approach options;
• Facilitate the development of dynamic knowledge management systems on product quality control throughout the Institute for use now and in the future;
• Draft and review Institute policies and practices and provide advice on changes to product quality control systems;
• Perform activities necessary for certification, accreditation, or registration of quality laboratories with necessary standards with relevant functional areas;
• Prepare presentations and relevant documentation for submission to regulatory authorities;
• Draft the Institute’s product quality control documents, reviewing for completeness and accuracy ensuring submissions meet strict deadlines for submission to the head of the department for timely transmission to regulatory authorities;
• Implement instruments for conducting regular and periodic audits on compliance with product quality control requirements for handling of chemical and use of instruments including liaising with the Quality Assurance Manager, conduct site inspections according to applicable regulations, SOPs, and work instructions;
• Generate advisories to relevant functional areas on product quality control requirements;
• Collect, collate, and evaluate scientific data on product quality control standards from a range of sources regarding manufactured products;
• Carry out risk mitigation strategies in the section;
• Draft product quality control-related strategic proposals for resource mobilization for the division; and
• Contribute to current innovation, technical and operational knowledge on matters affecting pharmaceutical industry through publications, editorials, among others