Principal Product Quality Control Officer KBI 5 at The Kenya Biovax Institute

Job Description

Job Purpose:
The Principal Quality Officer –Quality Control will be responsible for providing technical leadership
and performing operational functions to ensure that all product batches consistently meet
established quality standards, regulations and customer expectations by leading quality control
teams, implementing test procedures and identifying and resolving quality issues throughout the
production process.
Requirements:
1. At least seven (7) years’ experience in the relevant field, three (3) years of which must have
been in a Supervisory position in the Public or Private Sector;
2. Bachelor’s degree in any of the following field: Pharmacy, Life/ Biological Sciences
(Chemistry, Biochemistry, Biomedical Sciences, Microbiology) or its equivalent from a
recognized institution;
3. Maste’s degree in any of the following field: Pharmacy, Life/ Biological Sciences (Chemistry,
Biochemistry, Biomedical Sciences, Microbiology) or its equivalent from a recognized
institution;
4. Membership to a professional body where applicable;
5. Certification in Quality Management, Risk Management or any other relevant field;
6. Experience with preparation and execution of quality control filings, notifications, & technical
files for approval;
7. Management course lasting not less than four (4) weeks from a recognized institution;
8. Proficiency in computer applications;
9. Shown merit and ability as reflected in work performance and results; and
Job Specification
Key Competencies and skills
1. Working knowledge on product testing and analysis;
2. Strong analytical skills, decision making and problem-solving skills;
3. Excellent technical report writing skills and maintenance of quality documentation;
4. Compliance assurance and non-conformance management;
5. Continuous process improvement skills;
6. Knowledge of relevant legislation and regulations;
7. Strong organisational skills including planning, monitoring and controlling;
8. Leadership, supervisory, coaching and mentorship skills;
9. Conflict resolution and negotiation skills;
10. Integrity; and
11. Results-driven

Key Duties & Responsibilities
1. Supervising the execution of product quality control activities in liaison with other relevant
stakeholders;
2. Overseeing the implementation of measures for adequate identification and segregation of
test samples to avoid mix-up and cross-contamination
3. Overseeing the preparation of detailed instructions for each test and analysis;
4. Coaching and mentoring officers to ensure skill development and competency;
5. Oversees the maintenance of the sections records and information relating to product quality
control activities to ensure proper data handling;
6. Plan quality control activities to assure the quality of all products manufactured by the
Institute;
7. Acting 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;
8. Coordinate environmental monitoring and equipment validation as appropriate for evaluating
the adequacy of the manufacturing conditions with relevant functional areas;
9. Releasing or rejecting raw materials and intermediate products, if necessary;
10. Release or reject packaging and labelling materials and the final containers in which drugs
are to be placed;
11. Releasing or rejecting each lot of finished preparation;
12. Establishing 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
13. Ascertain the examination of returned preparations to determine whether such preparations
should be released, reprocessed or destroyed.
14. Proactively partner with Quality Assurance and Research & Development, and other relevant
functional areas to develop and maintain product specifications and analytical procedures;
15. Implementing policies, strategies, standards, procedures and guidelines and Quality
Management Systems on product quality control;
16. Liaising 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;
17. Sample, inspect and test as per specifications of raw materials, packaging materials, inprocess/intermediate product, and final/finished product for release or rejection and
documentation;
18. Reviewing and updating the adequacy and relevance of specifications & analytical
procedures in coordination with the quality assurance section;
19. Performing the calibration and preventive maintenance of instruments and types of
equipment as per schedule in collaboration with engineering and relevant functional areas;
20. Maintaining and update quality control records, control samples of raw material and finished
products of each batch manufactured;
21. Developing and executing measures aimed at reducing the proportion of scrap, waste, and
spoilage during the production process;
22. Maintaining and updating labelling procedure at all the stages and record;
23. Controlling sample storage;
24. Maintaining test records as per standard procedures for raw materials, packing materials, inprocess/intermediates, and finished products;
25. Ensuring product support services are provided satisfactorily after the products have been
sold;
26. Monitoring and maintaining up-to date knowledge on global product quality control
intelligence, provide impact evaluation to changing regulations and mitigation approach
options;
27. Facilitating the development of dynamic knowledge management systems on product quality
control throughout the Institute for use now and in the future;
28. Drafting and reviewing Institute policies and practices and provide advice on changes to
product quality control systems;
29. Performing activities necessary for certification, accreditation, or registration of quality
laboratories with necessary standards with relevant functional areas;
30. Preparing presentations and relevant documentation for submission to regulatory
authorities;
31. Drafting 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;
32. Implementing 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;
33. Generating advisories to relevant functional areas on product quality control requirements;
34. Collecting, collating, and evaluating scientific data on product quality control standards from
a range of sources regarding manufactured products;
35. Carrying out risk mitigation strategies in the section;
36. Drafting product quality control-related strategic proposals for resource mobilization for the
division; and
37. Contributing 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