Overview
Kairuki Pharmaceuticals Industry Limited (KPIL) is a new Pharmaceutical company which was established and registered by the country’s Business Registration & Licensing Agency (BRELA) back in 2015. The company is located at Zegereni Industrial Area in Kibaha Municipality, Coast region (Pwani). The plant is due to begin its manufacturing operations early 2021, therefore applications are invited from qualified and experienced Tanzanians in the pharmaceutical manufacturing industry for the following positions:
QUALITY CONTROL OFFICER (2) POSTS
Job Summary
- To oversee the activity of the quality control section and staff, developing, implementing, and maintaining a system of quality and reliability testing for the organization’s products and/or development processes.
- To prioritize, sample, test and release raw materials, intermediates and finished products to strict timescales, in order to support the business requirements
- To support the new formulations/finished products stability programme
- Timely approval of incoming batches, batch inspection and release according to KPIL SOPs
Job Description
- Monitoring stock transfers and physician sample lockers for compliance with labeled storage conditions
- Maintaining retained samples according to GMP
- Maintain QC master files for all registered products
- Handling deviations
- Sampling and testing of raw materials, intermediates and finished products using current pharmacopoeias, any associated “wet” chemistry and instrumental techniques (HPLC, IR, UV), as appropriate.
- Preparing Quality reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (CoA) for (finished products) and Stability reports.
- Creating and executing method development and method validation test for finished products and generating the appropriate analytical methods.
- Stability testing of products for new formulations and ongoing stability trials, using physical (pH viscosity) and instrumental (HPLC, UV) techniques, as appropriate.
- Writing/reviewing Standard Operating Procedures (SOPs).
- Calibrating analytical equipment, as and when required.
- Supporting all QC activities
- Ensuring good relations and communications with all members of the team and responding politely and in a fashion to internal and external customers
- Working with all members of staff to maintain and develop the positive progressive culture within The Specials Laboratory.
- Observing and complying with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
- Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Head of Department, for which training and/or an explanation has been provided and understood.
Essential Requirements:
- A scientific discipline (with strong chemistry content)
- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Highly proficient in the use of key analytical equipment (HPLC, IR, UV) and the testing of finished products.
- Experience of working in a GMP environment.
- Good IT skills e.g. Microsoft Office (Word, Excel and Outlook)
- Credible and confident communicator (written and verbal) at all levels.
- Highly customer focused and passionate about delivering excellent customer service.
- Ability to achieve and maintain high standards with meticulous attention to detail.
- First class planning, organizational and time management skills.
- Ability to work accurately in a busy and demanding environment, adhering to strict deadlines/timescales
- Strong analytical and problem solving ability.
- Self starter who can “hit the ground running”
- First class team player with a totally flexible approach.
- Hands on approach with a “can do” attitude.
- Self motivated with the ability to work proactively using own initiative.
- Committed to learning and development.
Education
- Diploma in Laboratory Sciences or microbiology; pharmaceutical sciences and technology; and other related sciences;
- Excellent computer skills, including MS Office;
- Strong communication skills, including the ability to explain and teach methodologies; and
- Understanding of manufacturing methods and procedures
Experience
- Five (5) to 10 years of quality control or combination of quality control and manufacturing experience in the parenteral pharmaceutical industry
- A minimum of five (5) years of management experience
Conduct and organize QMS Internal/External audit and ensure close out of all Inspection and Audit Non conformities
Mode of Application:
Interested candidates have to send their application letters attaching detailed curriculum vitae, certified copies of academic/professional qualification, testimonials and names, addresses, day time telephone numbers and email of three referees addressed to : Principal Promoter, Kairuki Pharmaceuticals Industry Limited, P.O. Box 65300, Dar es Salaam Or Email : info@kairukipharmaceuticals.org or knogahela@kairukipharmaceuticals.org. Please note that, all applicants should write the position applied as a subject on the application letter/on the email or on top of the envelope.
Closing date: Thirty (30) days from 30th September, 2020.
Only short-listed candidates will be contacted for interview.
