QUALITY ASSURANCE OFFICER – BOMRA 1063 views

 

 

REPORTS TO: Director-Licensing and Enforcement

 

JOB PURPOSE:

The purpose of the job is to manage, monitor, evaluate and coordinate the established laboratory quality system implemented at the National Quality Control Laboratory of the Botswana Medicines Regulatory Authority (BoMRA), as well as ensure compliance with the quality system in order to enhance its effective and efficient operation and improvement.

MAIN DUTIES:

• To ensure that the various quality systems are implemented and followed at all times (e.g. ISO/IEC 17025 and/or WHO Good Practices for Pharmaceutical Control Laboratories).
• Reporting to management on performance of the laboratory quality system(s) and any need for improvement.
• Responsible for statutory compliances requirements of the Laboratory. Promotion of awareness of customer requirements throughout the Laboratory as well as conducting customer feedback surveys. Responsible for liaison with the BoMRA Quality unit and accreditation bodies, where necessary, for all matters pertaining to the quality system.
• Monitor and liaise with the Laboratory manager to ensure the preventive maintenance and calibration of Laboratory equipment are on schedule .
• Liaise with the Laboratory manager to ensure that Laboratory participates in Proficiency testing/lnterlaboratory testing scheme Coordinate and prepare for laboratory internal audits.

QUALIFICATIONS

Education

• A degree in chemistry, pharmacy, biology, microbiology, or life sciences Work Experience
• Minimum 5 years’ experience in pharmaceutical industry or in a laboratory that has implemented a laboratory management system.

Technical Competencies

• Training including internal auditing on ISO/IEC 17025:2017.
• ISO 9001:2015 training.
• Proven record of development, implementation and monitoring of a management system.
• Good working knowledge of implementing and using continuous improvement tools.
• Experience with implementation of corrective action programs.

Knowledge, Skills and Abilities:

• Excellent communication and presentation skills, both verbal and written. Experience with QMS and/or working in CMP environment.