UNOPS Guatemala is looking for a professional for the position of: Pharmaceutical Products Quality Assurance Specialist .

The Pharmaceutical Products Quality Assurance Specialist must, together with the technical team led by the Technical Specialist in Medicines and Medical Supplies and the Advisor, guarantee that the batches of medicines and healing materials delivered to the associate comply with the requirements. quality standards, and that they conform to what was offered and actually contracted. She will support the Advisor in the formulation of the methodology and activities for quality assurance. In coordination with the Technical Specialist in Medications and Medical Supplies, she must plan and execute the audits and sample collection to be sent to laboratories recognized by the Guatemalan authorities for evaluation. The Specialist will have the following functions and responsibilities:

I. Technical advice in the procurement and quality control process

• Contribute to the formulation of the methodology for quality assurance of batches of medicines and healing materials.
• Contribute to the selection of the deposit that will be used for countersampling of medications that are subjected to the quality assurance process.
• Supervise the activities carried out in the field regarding adherence and compliance with regulatory aspects regarding good manufacturing practice and good storage practices in accordance with the national legislation of Guatemala.

II. Delivery of technical assistance products

• Carry out institutional strengthening activities agreed upon with the partner, according to the guidance and supervision of the Advisor.
• Prepare technical documents in areas of your competence.

III. Works team management

• Supervise multidisciplinary work teams.
• Facilitate the commitment and provision of high quality results and services of the supervised team through effective work planning, performance management, coaching and promotion of learning and development.

IV. Facilitation of knowledge construction and knowledge sharing

• Organize, facilitate and deliver training and learning initiatives for staff related to quality assurance issues.
• Lead and implement initiatives on capacity building and knowledge development for technical staff, including the development of networks, learning plans and activities and information on quality assurance practices and benchmarking of best practices.
• Collect comments, ideas and internal knowledge about processes and good practices and their productive use.

+++For more information about the position and to submit applications, review the vacancy publication and the TDR directly on the UNOPS JOBS platform+++

Requirements

A. Education

• A higher university degree is required, equivalent to a Master’s degree, preferably in Pharmacy, Medicine, Chemical Engineering, Bioengineering, Pharmacovigilance or another related field.
• A university level Bachelor’s Degree (equivalent to a Bachelor’s Degree) preferably in the areas mentioned above, in combination with seven (07) years of experience, may be considered if you do not have a higher education degree (Master’s Degree).
• Relevant certifications in procurement and drug quality assurance will be a distinct advantage.

B. Experience

• 5 to 7 years of professional experience (or more depending on the academic qualifications presented) in quality assurance management of medicines and healing materials, preferably in coordination, team leadership or senior consultant positions.
• Use of computers and office software packages, such as documents, spreadsheets, preferably Google Suite or MS Office, in turn.

Experience in:

• International organizations such as the United Nations, multilateral and bilateral entities or governments.
• Matter of quality assurance of medicines and healing materials in countries with National Regulatory Agencies IV, according to the PAHO classification.
• Knowledge of regulation of good manufacturing and warehousing and storage practices in Guatemala and/or countries in Central America and/or Latin America for the importation of medicines.

C. Language

• Mastery of the Spanish language is required.
• Intermediate English language proficiency is desirable.