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

The Kenya BioVax Institute is a State Corporation tasked with the mandate of manufacturing, packaging and commercialization of specialized Health Products and Technologies (HPTs) that include vaccines, therapeutics and other biomedical products.

 

Principal Product Quality Control Officer KBI 5

  • Job TypeFull Time
  • QualificationBA/BSc/HND , MBA/MSc/MA
  • Experience7 years
  • LocationNairobi
  • Job FieldPharmaceutical  , Science 

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:

  • 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;
  • 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
  • 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;
  • 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

Job Specification

Key Competencies and skills

  • Working knowledge on product testing and analysis;
  • Strong analytical skills, decision making and problem-solving skills;
  • Excellent technical report writing skills and maintenance of quality documentation;
  • Compliance assurance and non-conformance management;
  • Continuous process improvement skills;
  • Knowledge of relevant legislation and regulations;
  • Strong organisational skills including planning, monitoring and controlling;
  • Leadership, supervisory, coaching and mentorship skills;
  • Conflict resolution and negotiation skills;
  • Integrity; and
  • Results-driven

Key Duties & Responsibilities

  • Supervising the execution of product quality control activities in liaison with other relevant stakeholders;
  • Overseeing the implementation of measures for adequate identification and segregation of test samples to avoid mix-up and cross-contamination
  • Overseeing the preparation of detailed instructions for each test and analysis;
  • Coaching and mentoring 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;
  • Plan quality control activities to assure the quality of all products manufactured by the Institute;
  • 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;
  • Coordinate environmental monitoring and equipment validation as appropriate for evaluating the adequacy of the manufacturing conditions with relevant functional areas;
  • Releasing or rejecting 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;
  • Releasing or rejecting each lot of finished preparation;
  • 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
  • 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;
  • Implementing policies, strategies, standards, procedures and guidelines and Quality
  • Management Systems on product quality control;
  • 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;
  • 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;
  • Reviewing and updating the adequacy and relevance of specifications & analytical procedures in coordination with the quality assurance section;
  • Performing the calibration and preventive maintenance of instruments and types of equipment as per schedule in collaboration with engineering and relevant functional areas;
  • Maintaining and update quality control records, control samples of raw material and finished products of each batch manufactured;
  • Developing and executing measures aimed at reducing the proportion of scrap, waste, and spoilage during the production process;
  • Maintaining and updating labelling procedure at all the stages and record;
  • Controlling sample storage;
  • Maintaining test records as per standard procedures for raw materials, packing materials, inprocess/intermediates, and finished products;
  • Ensuring product support services are provided satisfactorily after the products have been sold;
  • Monitoring and maintaining up-to date knowledge on global product quality control intelligence, provide impact evaluation to changing regulations and mitigation approach options;
  • Facilitating the development of dynamic knowledge management systems on product quality control throughout the Institute for use now and in the future;
  • Drafting and reviewing Institute policies and practices and provide advice on changes to product quality control systems;
  • Performing activities necessary for certification, accreditation, or registration of quality laboratories with necessary standards with relevant functional areas;
  • Preparing presentations and relevant documentation for submission to regulatory authorities;
  • 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;
  • 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;
  • Generating advisories to relevant functional areas on product quality control requirements;
  • Collecting, collating, and evaluating scientific data on product quality control standards from a range of sources regarding manufactured products;
  • Carrying out risk mitigation strategies in the section;
  • Drafting product quality control-related strategic proposals for resource mobilization for the division; and
  • Contributing to current innovation, technical and operational knowledge on matters affecting pharmaceutical industry through publications, editorials, among others
     

Method of Application

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:

  • Letter of Application (Indicate Vacancy Number)
  • Current Resume or Curriculum Vitae with telephone number and e-mail address
  • Three letters of professional reference with contact telephone numbers and e-mail addresses
  • Copies of Academic Certificates and Transcripts

Interested and qualified persons are required to make their applications ONLINE through the

Kenya BioVax E-recruitment link: https://recruitment.biovax.go.ke so as to reach the Institute on or before 18 th March, 2025 latest 5.00 pm East African Time.

Only ONLINE applications shall be accepted.
THE KENYA BIOVAX INSTITUTE IS AN EQUAL OPPORTUNITY EMPLOYER; WOMEN, TH MARGINALISED AND DISABLED PERSONS ARE ENCOURAGED TO APPLY.
THE KENYA BIOVAX INSTITUTE DOES NOT CHARGE A FEE AT ANY STAGE OF ITS SELECTION PROCESS INCLUDING APPLICATION, INTERVIEW MEETING AND PROCESSING OF OFFER LETTER. 

Interested and qualified? Go to The Kenya BioVax Institute on recruitment.biovax.go.ke to apply

Comments

Post a Comment

Popular posts from this blog

Operations Associate at Kopo Kopo Inc

Kopo Kopo was launched in 2012 where we partnered with Safaricom to bring Lipa na M-Pesa Buy Goods service to small and medium businesses throughout Kenya and, today, we serve thousands of businesses from salons to restaurants to office supply stores, to schools. We have since partnered with other aggregator and mobile money partners with the ultimate goal of helping businesses leverage mobile payments. We are grateful for our unusual journey and look forward to helping our merchants in growing and prosper in the years ahead.   Operations Associate Job Type Full Time Qualification BA/BSc/HND Experience Location Nairobi Job Field Customer Care  Salary Range KSh 50,000 - KSh 100,000/month The Job:   The role will combine aspects of customer service and operations duties. Ultimately, you will be responsible for quickly solving problems for businesses that rely on Kopo Kopo’s technology. You will ensure that Kopo Kopo’s information systems are kept up to date, and will engage...
Read more

Senior Communications Officer at Natural State

Through large-scale restoration and rewilding, NATURAL STATE secures biodiversity, sequesters and stores carbon, and helps achieve the Sustainable Development Goals. Our goal at the NATURAL STATE research centre is to develop technology and financial systems that will catalyse large-scale restoration globally as well as help train future leaders for this...   Senior Communications Officer Job Type Full Time Qualification BA/BSc/HND Experience 8 years Location Nairobi Job Field Media / Advertising / Branding  Senior Communications Officer to lead our communications strategy, focusing on scientific, climate, and nature restoration initiatives. The ideal candidate will play a pivotal role in enhancing our brand presence, driving engagement, and conveying the impact of our work on preserving and restoring natural ecosystems. This position requires a blend of communications expertise, strategic thinking, and a deep understanding of climate, nature restoration, and scientific topics...
Read more

Project Director at LVCT Health

LVCT Health is an indigenous Kenyan non-governmental and not-for-profit organization established in 2001. We are driving Kenya towards HIV prevention, with an ultimate goal of reducing HIV infections to zero. We offer integrated HIV services through development of models that are scaled up to the national models. We also carry out sexual and reproductive ...   Project Director Job Type Full Time Qualification MBA/MSc/MA Experience 7 - 10 years Location Kiambu Job Field Medical / Healthcare  Job purpose The Project Director will be responsible for providing overall strategic and technical oversight to the Dhibiti Project in Central region. This includes responsibility for the technical, monitoring and evaluation and financial and operations components of the project. S/he will work closely with the Program Director and other directors/managers to ensure adherence to technical and contractual requirements of the grant, achievement of targets and project alignment to institutiona...
Read more