Intrinseque Health
Website:
intrinsequehealth.com
Job details:
This role involves implementing and maintaining quality assurance processes to support clinical supply chain operations, including reviewing and updating SOPs, quality manuals, and documentation to meet regulatory and certification requirements. The Quality Assurance Executive will conduct internal quality audits, assist in vendor and supplier audits, and monitor corrective and preventive actions to ensure continuous improvement. Daily responsibilities include coordinating with operations and project teams to ensure compliance with ISO and GDPMDS standards, managing quality records, supporting training on QA procedures, and preparing periodic quality reports and metrics for management review.
Qualifications
- Candidates should possess strong skills in Quality Assurance and Quality Management, including developing, implementing, and monitoring QA systems and policies.
- Candidates should possess skills in Quality Control, with experience in inspections, testing, and monitoring processes to ensure adherence to defined standards.
- Candidates should possess capabilities in Quality Auditing, including planning and conducting internal audits and supporting external or regulatory audits.
- Candidates with a background in Food Technology or related scientific disciplines, and an understanding of regulated environments, will be preferred.
- Bachelor’s degree in science, pharmacy, engineering, or a related field; prior experience in quality functions within healthcare, pharmaceutical, clinical research, or medical devices is beneficial.
- Knowledge of ISO standards (such as ISO 9001, ISO 13485, ISO 27001) and good documentation practices, with strong attention to detail.
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