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About this job
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:
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 patients.
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 observations.
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 staff.
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
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.
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:
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 patients.
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 observations.
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 staff.
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
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.