Consulting and StrategyConsultantMid-level(3-5 yrs)
Job Description
Information about the role
The Product Quality Assurance Consultant will be responsible for the technical review of submitted Quality Assurance (QA) documentation for health products based on the GDF QA Policy. This role involves verifying manufacturer compliance, validating international certifications like ISO 13485/9001, and performing technical due diligence on accreditation statuses.
Key Responsibilities
Technical Review: Conduct in-depth reviews of QA documentation for products per the GDF QA Policy.
Compliance Verification: Check and verify manufacturer's QA and regulatory documents for compliance.
Certification Validation: Authenticate ISO 13485/9001 or equivalent and other relevant certifications. Perform technical due diligence on certifications and verification of accreditation status, including assessment of risks and implications.
Communication: Draft and submit questions for clarification as needed and assess additional evidence submitted in response.
Reporting: Prepare comprehensive QA evaluation reports for each product reviewed, including risk assessments and formal recommendations (accept, request more info, or reject).
Advisory: Provide technical advice to GDF management on quality assurance risks, regulatory compliance trends, and related issues.
Data Security: Ensure compliance with GDF’s data handling and confidentiality policies regarding sensitive or proprietary information.
Required Skills and Competencies
Strategic Thinking: Develops and implements sustainable business strategies and thinks long-term.
Integrity: Treats all individuals with respect, upholds organizational norms, and maintains high standards of trustworthiness.
Teamwork: Acts as a positive role model contributing to team spirit and supports the development of others.
Partner Orientation: Understands the impact of the role on partners and beneficiaries, maintaining strong relationships.
Results Orientation: Establishes appropriate courses of action to accomplish goals with a focus on quality and resource efficiency.
Adaptability: Open to change and flexible in a fast-paced environment, reflecting on experiences to modify behavior.
Analytical Thinking: Evaluates data and courses of action to reach logical decisions and applies innovation to problem-solving.
Communication: Expresses ideas clearly and concisely, actively listens, and proactively shares knowledge.
Qualifications and Experience Requirements
Education: A Master’s degree in pharmaceutical sciences, biomedical engineering, biological sciences, or a related field is required. A bachelor's degree with an additional 2 years of experience may be considered in lieu of a master’s degree.
Experience: At least 5 years of experience in Quality Assurance for medical devices and/or other health products is required.
Regulatory Knowledge: Experience in in-vitro diagnostics and in applying relevant regulatory frameworks (IMDRF, WHO Prequalification, EU MDR 2017/745, EU IVDR 2017/746, FDA 21 CFR Part 820, or equivalent) is required.
Assets: A proven track record evaluating products' QA submissions from manufacturers' dossiers and experience in Compliance with Good Manufacturing Practices (GMP) requirements is an asset.
Interested and qualified candidates should apply online through the UNOPS careers portal. To apply, visit: https://www.myjobmag.co.ke/apply-now/1182665. Ensure that your application clearly demonstrates how you meet the required qualifications and experience levels.
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