Product Quality Assurance Consultant (Roster)

ABOUT THE COMPANY

The United Nations Office for Project Services (UNOPS) is an operational arm of the United Nations, supporting the successful implementation of its partners' peacebuilding, humanitarian and development projects around the world.

JOB SUMMARY

Education RequirementsRequiredA Master’s degree in pharmaceutical sciences, or biomedical engineering, or biological sciences, or  a related field  is required.A bachelor's with an additional 2 years of experience may be considered in lieu of a master’s degree.Experience RequirementsRequiredAt least 5 years of experience in Quality Assurance for medical devices and/or other health products is requiredExperience in in-vitro diagnostics and in applying relevant regulatory frameworks, including but not limited to IMDRF, WHO Prequalification, EU MDR 2017/745, EU IVDR 2017/746, FDA 21 CFR Part 820, or equivalent standards, is requiredProven track record evaluating products' QA submissions from manufacturers' dossiers is an asset.Experience in Compliance with Good Manufacturing Practices requirements for suppliers and manufacturers is an asset

RESPONSIBILITIES

In depth technical review of submitted QA documentation per product based on the GDF QA Policy.Check and verify the manufacturer’s QA and regulatory documents for compliance.Validate the authenticity and validity of ISO 13485/9001 or equivalent and other relevant certifications. Perform necessary technical due diligence on certifications and verification of accreditation status, including assessment of risks and implications Confirm that certificates were issued by accredited notified bodies and are still valid.Draft and submit questions for clarification as needed.Assess any additional evidence submitted in response.Prepare comprehensive QA evaluation reports for each product reviewed, including risk assessments and formal recommendations. Provide technical advice to GDF management on  quality assurance risks, regulatory compliance trends and related issues, as may be requiredData Security: Submissions may contain sensitive or proprietary information requiring the consultant to comply with GDF’s data handling and confidentiality policies.

REQUIRED SKILLS

Quality control and supervision, Quality management, Project management, Pharmaceutical manufacturing

REQUIRED EDUCATION

Bachelor's degree