5 Oct 2020

Head Of Quality Assurance at Kairuki Pharmaceuticals Industry Limited

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Kairuki Pharmaceuticals Industry Limited

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:

Employment type: Full – Time
Location: Zegereni Industrial Area in Kibaha Municipality

HEAD OF QUALITY ASSURANCE (1) POST

Reporting Line: Plant Manager

Job Summary

  • The Head of Quality unit’s key role is to ensure KPIL products are manufactured and distributed according to Tanzania Medicines & Medical Devices Authority (TMDA) regulations. This function maintains quality compliance with Good Manufacturing Practices (GMP) and KPIL standard Operating procedures (SOPs).
  • The quality function also ensures the timely release of incoming product batches into the market place for sale, assisting KPIL in meeting financial sales targets and ensuring that quality product is available to

Interactions and Interface

  • Internally this position interacts with all departments at KPIL, in particular Logistics and Medical information, and the Quality Control & Quality Assurance sections.
  • Externally this position interacts with Ministry of Health, Women, Gender Development, Elderly and Children, third party logistics, whole salers and distributors, industry organizations, consultants, vendors, and health care professionals.

GENERAL RESPONSIBILITIES

Quality Assurance – Responsible for the following

  • Coordinates new launch shipments
  • Handling of product complaints
  • Development, periodic review, revision and implementation of SOPs as required
  • Annual product reviews and review of stability reports for compliance with TMDA
  • QA annual self-inspection and quality agreements with manufacturers, wholesalers and distributors
  • Conducting inspection of distributors and wholesalers as necessary per GMP requirements
  • Acting as primary quality contact person with Third Party Logistics (3PL) and qualified person for internal quality contact person for internal quality compliance matters
  • Implement recall procedures if necessary
  • Monitoring QA aspects of warehousing practices for compliance with warehouse procedure manuals (Third Party Logistics – 3PL)
  • Liaising with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to
  • Training of sales representative on physician sampling handling and distribution
  • Overseeing the maintenance and renewals of Drug Establishment Licence(s)
  • Periodic GMP training for relevant

Quality Control – Responsibilities include

  • Timely approval of incoming batches, batch inspection and release according to KPIL SOPs
  • Handling deviations
  • 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

Miscellaneous

  • Manage outsourced activities and consultants as needed
  • Responding to NEMC notices
  • Participate in personal development and training sessions
  • Work in a safe manner that does not endanger yourself or core-workers
  • Strive to consistently uphold KPIL’s core values
  • Execute other duties as may be required by the Plant Manager

Skills and Qualifications

  • In Science with analytical chemistry/manufacturing background
  • 5 plus years relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs
  • Experience with TMDA inspections and third party audits
  • Understanding of of pharmaceutical manufacturing and laboratory work (including familiarity with various analytical techniques) a strong asset
  • Detail oriented person
  • Solid decision making skills
  • Excellent communication skills (Verbal, written, listening, conveying messages)
  • Solid computer skills, using MS office, MS-WORD and Lotus Notes

 

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      Method 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[email protected] or [email protected]

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.

Only short-listed candidates will be contacted for interview.

The deadline for submitting the application is October 30, 2020






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