Job Description
Job Title
Senior Product Quality Officer – Quality Assurance
Job Description
Position: Senior Product Quality Officer – Quality Assurance
Location: Nairobi County
Reporting: Principal Product Quality Officer – Quality Assurance
About the Institute:
The Kenya BioVax Institute is a State Corporation tasked with the manufacturing, packaging and commercialization of specialized Health Products and Technologies (HPTs) that include vaccines, therapeutics and other biomedical products.
Job Purpose:
The Senior Product Quality Officer – Quality Assurance shall coordinate product quality assurance activities and execute adherence to applicable requirements for each product being manufactured by the Institute while giving guidance to achieve compliance 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:
1. At least four (4) years’ experience in the relevant field;
2. Bachelor Degree in any of the following fields: Pharmacy, Life/Biological Sciences (Chemistry, Biochemistry, Biomedical Sciences, Microbiology) or its equivalent from a recognized institution;
3. Demonstrated merit and ability in administrative, and professional competence in work performance and results;
4. Membership to a relevant professional body
Job Specification
Key Competencies and skills
1. Good writing and communication skills;
2. Organizational skills including planning, monitoring and controlling;
3. Interpersonal skills;
4. Ability to work under pressure;
5. Team building;
6. Detail-oriented;
7. Adaptability;
8. Accountability;
9. Problem-solving;
10. Sound decision making skills;
11. Integrity; and
12. Results-driven
Key Duties & Responsibilities
1. Manage all Quality Assurance Committee documentation including policy documents, manuals, meeting minutes and work procedures;
2. Oversee the preparation of detailed work allocation and section services coordination;
3. Promote and generate a strong quality culture within the Institution through effective collaboration with peers; Develop validation and verification plans for product quality assurance and ensuring the activities outlined in the plans are conducted;
4. Develop quality assurance compliance records to facilitate overall release of the product, in collaboration with relevant functional areas;
5. Support liaison with National or International quality authorities for qualification, certification and validation of the product manufacturing processes, licenses and renewals of the same and any other regulatory quality requirements;
6. Participate in the drafting of the Institute’s regulatory documents including Quality policies, systems policies, standards and procedures on product quality assurance;
7. Conduct regular and periodic audit on compliance with regulatory requirements including liaising with the Quality Control Manager, conduct site inspections according to applicable regulations, SOPs, and work instructions;
8. Draft advisories for management to relevant functional areas including Research and Development scientists and Production departments on regulatory requirements;
9. Collect, collate, and evaluate scientific data on standards from a range of sources regarding manufactured products;
10. Coordinate the development of Quality Assurance specifications and analytical procedures in liaison with Research and Development and Product Quality Control;
11. Keep up to date with national and international legislation, guidelines, and customer practices and facilitate adaptation into Institutional documents;
12. Execute risk mitigation strategies in the section;
13. Provide regular, thorough and prompt communication to the Principal Product Quality Officer on key technical, financial and administrative matters;
14. Contribute to current innovation, technical and operational knowledge on matters affecting pharmaceutical industry through publications, editorials, among others.
Terms of Service
The successful applicant will be appointed for five (5) year contract term and may be eligible for reappointment as per the Kenya BioVax Human Resource Policy and Procedures Manual.
Applications should include the following:
1. Letter of Application (Indicate Vacancy Number)
2. Current Resume or Curriculum Vitae with telephone number and e-mail address
3. Three letters of professional reference with contact telephone numbers and e-mail addresses
4. Copies of Academic Certificates and Transcripts
Grade
KBI 6
No Sought
1
Advert Ref
KBI/52/02/2024
Recruitment
February Recruitment 2024