Quality Control Consultant
UNITED STATES PHARMACOPEIA - all the provinces, all the provinces
Offre d'emploi fermée
The United States Pharmacopeial convention was awarded a 16-months contract to build the capacity of technical staff of the National Quality Control Laboratory (NQCL) – LAPHAKI - of the Democratic Republic of Congo (DRC) to detect and identify poor quality medical products according to international best practices of accreditation.
To successfully implement this project, USP is seeking a Short-term In-country Quality Control Consultant to manage day-to-day in-country activities for the duration of this project.
The in-country consultant will have the overall responsibility of supporting the implemention of laboratory quality management systems (QMS) in the laboratory and to assure that the laboratory conducts its technical activities according to international standards of ISO 17025.
The consultant will also be responsible for managing material, financial and technical resources of USP and that of the project in the country.
The consultant will report to the Project Manager/Africa Regional Director, with technical line of reporting to the Director of Laboratory Program Unit.
Scope of Work:
Provide in-country oversight of the day-to-day project implementation by working with the lab and stakeholders to build laboratory quality management system.
Working with the laboratory, lead the development of standard operating procedures (SOPs), quality manual, quality policy and good documentation practices per the requirement of ISO 17025.
Identify and work with in-country implementing partners and donors, with interest in medicine quality control, as well as the MoH to develop or adopt national laboratory strategic plans.
Working with USP international consultants, provide short-term technical assistance training to laboratory staff in good laboratory practices, laboratory safety, analytical methods and instrumentation.
Provide oversight for continuous equipment maintenance and validation and support external consultants and vendors to conduct equipment calibration and qualification.
Provide in-country project management leadership through planning, executing and monitoring of USP’s financial, materials and technical resources, with support from the Project Manager.
Attend all meetings and workshops organized under the project.
Facilitate trainings as per the project workplan.
Provide periodic updates to the program director and manager on LAPHAKI and DPM activities and assignments.
Assist in drafting and reviewing project reports for submission to CFEF.
Assist in translating from French to English and vice versa as needed.
Facilitate all logistics arrangements for USP project staff and international consultants when in-country.
Coordinate with USP, LAPHAKI, DPM, CFEF and other relevant stakeholders the procurement, shipment, clearing and transportation to LAPHAKI of laboratory equipment and consumables.
Other assignments requested by the program director/manager.
• Bachelor’s degree in chemistry, biochemistry, pharmacy, pharmaceutical/life science or related field.
• At least 5 years professional experience working in a Quality Control laboratory either within a pharmaceutical manufacturing company or a medicines regulatory authority.
• At least 2 years’ experience in project management support/coordination.
Knowledge, Skills and Abilities:
• Ability to work independently and to effectively liaise with relevant parties, including government and non-government stakeholders.
• Must be proficient in English and French and possess excellent verbal, written and presentation skills.
• Must have basic project management skills.
• Computer proficiency in Word, Excel, PowerPoint, and Internet.
• Firm knowledge of the operations of drug regulatory authorities and national quality control laboratories.
• Understand the basics of monitoring and evaluation of program activities.
• High level of integrity and commitment to quality.
• Must possess ability to handle multiple priorities in a fast-paced environment.
• Ability to write lucid technical and management reports in English, preferred.
• Ability to travel within DRC.
• Congolese nationals preferred; this is an in-country support and no relocation will be provided
Interested candidates should submit cover letter, CV through thiw website clearly stating consultancy for which the applicant is applying for in the subject line of their application e-mail