Quality Assurance Associate [Medicines and Medical Supplies] At UNOPS

At UNOPS, we celebrate diversity and are committed to equal employment opportunities. We encourage qualified individuals to apply, as well as all people who meet the qualifications of the position, especially those from racialized or indigenous groups, people with diverse gender identities and sexual orientations, and people with disabilities.

Please note that this is a local vacancy and is available to candidates of Guatemalan nationality.

Our work contributes to building the foundations for countries and communities to achieve peace and sustainable development, guided by our values: Inclusion, Integrity, Humility and Humanity.

Key Features:

I. Support for inspection and sampling processes:

• Develop the sampling design proposal.
• Comply with the methodology for quality assurance of batches of medicines and medical supplies contracted by the Project.
• Carry out the inspection by product attributes contracted by the Project, including the following activities:
  • Go to the indicated warehouses where the product inspection will be carried out;
  • Use and analyze ANSI (American National Standards Institute) tables or other recommended tables such as ISO 2859, for statistical sampling and identify units according to statistical sampling;
  • Verify each unit with respect to the quality attributes established and committed to in the contract for the different products;
  • Compare delivery orders with medications in warehouses;
  • Prepare reports on the inspection process.
• Carry out product sampling for quality analysis of the medicines and supplies contracted by the Project and support the assembly of the respective analysis tests;
  • Go to the designated warehouses where the samples will be taken and ensure due diligence when delivering them to the laboratory designated for analysis;
  • Check delivery orders for medications or medical supplies;
  • Compare delivery orders with medications in warehouses;
  • Check all aspects and characteristics of the medicines and healing materials to be sampled;
  • Safeguard the samples until they reach the corresponding laboratory if necessary.
  • Provide support in monitoring the analysis processes developed in Quality Control laboratories if required.
  • Verify that the results are within specifications in the results of each of the tests listed in the Product Analysis Certificates.
• Support the verification of compliance with Good Manufacturing, Storage and Distribution Practices of contractors and/or strategic allies such as Logistics Operators.

II. Support for document management:

• Record the documentation of the Quality Assurance area: registration, organization and corresponding distribution, as appropriate.
• Periodic reviews of regulatory authority databases regarding notifications related to pharmacovigilance or the quality of medicines and supplies.
• Organize project documents in a timely, secure and efficient manner.
• Ensure relevant documents are organized and archived in the Shared Drive.
• Support the Quality Assurance team with document management and implement the established guide and/or procedure (Document Management SOP).

***For further information on the job functions, please review the attached TDR in the UNOPS JOBS publication .***

Requirements:

A. Education

• High school diploma required.
• Candidates who have a Bachelor’s or Technical Degree in health disciplines, preferably in chemistry or pharmacy, will be considered; they may replace some of the required years of experience.

B. Experience

• A minimum of 2 to 6 years of experience (depending on the academic degree provided) is required in the pharmaceutical industry, preferably in the area of ​​quality assurance, quality control or regulatory affairs.

Will be valued:

• Experience in the health area related to medications, hospital/medical-surgical material or medical devices.
• Experience in international organizations or in the humanitarian sector.

C. Language

• Fluency in Spanish.
• Intermediate level of English desirable.
• Knowledge of the Mayan language desirable.

D. Work Environment

• This role will be performed at the UNOPS Guatemala Office, currently located in Zone 10 of Guatemala City.
• The work is 100% in person, 5 days a week (Monday-Friday).
• The office does not provide parking, however, there are nearby parking lots that, if required, must be paid for personally and individually.
• UNOPS would like to ensure that all candidates are able to perform to the best of their ability during the assessment process. If you are selected and require additional assistance during the selection process (such as reasonable accommodations), please inform the HR person when you receive the invitation.

***Please upload your academic diplomas or relevant academic transcripts to your application***