Background

The Zambia Medicines Regulatory Authority (ZAMRA) is a statutory body established under the Medicines and Allied Substances Act, Chapter 299 of the Laws of Zambia, responsible for the regulation of medicines and allied substances in Zambia. The Authority invites applications from suitably qualified Zambian citizens who are ambitious, innovative, energetic and performance-driven to apply for the following positions:

5. LABORATORY ANALYST – PHYSICO-CHEMICAL (1)

Job Purpose

To carry out physico-chemical analysis of medicines and allied substances in accordance with pharmacopoeial and validated methods, within the laboratory’s quality management system, in order to ensure that only products of acceptable quality are available on the Zambian market.

Person Specifications and Qualifications

• Full Form V/Grade 12 School Certificate with five (5) ‘O’ Level credits or better, including English, Mathematics and Chemistry;
• Bachelor of Pharmacy Degree, Bachelor of Science in Chemistry, Analytical Chemistry or any related science;
• A minimum of two (2) years’ relevant work experience in a pharmaceutical or analytical quality control laboratory; and
• Membership to relevant professional body.

Required Skills and Attributes

• Practical experience in the use of analytical instruments such as HPLC, GC, UV-Visible and FTIR spectrometers, dissolution testers and Karl Fischer titrators;
• Knowledge of ISO/IEC 17025 and Good Laboratory Practice will be an added advantage;
• Good analytical skills and attention to detail;
• Proficiency in computer skills, including laboratory data management systems;
• Good planning and organisation skills;
• Ability to work under minimal supervision and as part of a team;
• Good report writing and communication skills; and
• Ability to handle confidential and sensitive information.

Duties and Responsibilities

• Conduct physico-chemical analysis of samples of medicines and allied substances submitted for registration, post-marketing surveillance and investigation, using compendial (BP, USP, Ph. Int.) and validated methods;
• Undertake verification and validation of analytical methods in order to ensure the reliability of test results;
• Accurately record, review and report analytical results and prepare Certificates of Analysis;
• Operate, calibrate and carry out routine maintenance of laboratory equipment in order to ensure accuracy and continuity of testing;
• Receive, register, store and dispose of samples in accordance with laboratory procedures, maintaining the chain of custody;
• Manage reference standards, reagents and laboratory consumables;
• Investigate out-of-specification results and implement appropriate corrective and preventive actions;
• Participate in proficiency testing and inter-laboratory comparison schemes;
• Implement and maintain the laboratory quality management system in line with ISO/IEC 17025 and WHO requirements;
• Contribute to the development and review of standard operating procedures and work instructions;
• Observe laboratory health, safety and environmental requirements; and
• Perform any other duties as may be assigned by the supervisor.

Additional Notes

Candidates are required to have their qualifications verified by the Zambia Qualifications Authority (ZAQA) before submitting their applications. Envelopes should be appropriately marked in respect of the position applied for. Only shortlisted candidates will be invited for interviews. ZAMRA is an equal opportunity employer, and we encourage applications from qualified individuals of all backgrounds.

• Conduct physico-chemical analysis of samples of medicines and allied substances submitted for registration, post-marketing surveillance and investigation, using compendial (BP, USP, Ph. Int.) and validated methods;
• Undertake verification and validation of analytical methods in order to ensure the reliability of test results;
• Accurately record, review and report analytical results and prepare Certificates of Analysis;
• Operate, calibrate and carry out routine maintenance of laboratory equipment in order to ensure accuracy and continuity of testing;
• Receive, register, store and dispose of samples in accordance with laboratory procedures, maintaining the chain of custody;
• Manage reference standards, reagents and laboratory consumables;
• Investigate out-of-specification results and implement appropriate corrective and preventive actions;
• Participate in proficiency testing and inter-laboratory comparison schemes;
• Implement and maintain the laboratory quality management system in line with ISO/IEC 17025 and WHO requirements;
• Contribute to the development and review of standard operating procedures and work instructions;
• Observe laboratory health, safety and environmental requirements; and
• Perform any other duties as may be assigned by the supervisor.

• Practical experience in the use of analytical instruments such as HPLC, GC, UV-Visible and FTIR spectrometers, dissolution testers and Karl Fischer titrators;
• Knowledge of ISO/IEC 17025 and Good Laboratory Practice will be an added advantage;
• Good analytical skills and attention to detail;
• Proficiency in computer skills, including laboratory data management systems;
• Good planning and organisation skills;
• Ability to work under minimal supervision and as part of a team;
• Good report writing and communication skills; and
• Ability to handle confidential and sensitive information.

• Full Form V/Grade 12 School Certificate with five (5) ‘O’ Level credits or better, including English, Mathematics and Chemistry;
• Bachelor of Pharmacy Degree, Bachelor of Science in Chemistry, Analytical Chemistry or any related science;
• A minimum of two (2) years’ relevant work experience in a pharmaceutical or analytical quality control laboratory; and
• Membership to relevant professional body.