job description
Join Intrinseque Health as a Quality Assurance Specialist and play a pivotal role in ensuring the highest standards of research integrity and healthcare advancement. Based in the vibrant and culturally rich region of Bali, Indonesia, this opportunity allows you to contribute to cutting-edge medical research while shaping quality protocols in a forward-thinking organization.
As a QA Specialist, you will collaborate with cross-functional teams to implement, monitor, and enhance quality control systems that align with global healthcare standards. Your expertise will directly impact patient safety, regulatory compliance, and the overall efficacy of medical innovations. This role is ideal for detail-oriented professionals passionate about driving excellence in healthcare through meticulous quality assurance practices.
Intrinseque Health is committed to fostering a dynamic work environment where your contributions are valued, and your growth is supported. If you are eager to make a meaningful difference in the medical field while working in one of the worldâs most inspiring locations, we invite you to apply.
Responsibility
- Develop, implement, and maintain quality assurance policies, procedures, and standards in compliance with local and international healthcare regulations.
- Conduct regular audits and inspections of research processes, documentation, and facilities to ensure adherence to quality benchmarks.
- Identify, document, and report quality deviations or non-conformities, and recommend corrective and preventive actions (CAPA).
- Collaborate with research, clinical, and operational teams to integrate quality assurance best practices into daily workflows.
- Prepare and review quality-related documentation, including SOPs, audit reports, and compliance records.
- Monitor and analyze quality metrics to drive continuous improvement in research and healthcare delivery.
- Provide training and guidance to staff on quality assurance principles, regulatory requirements, and internal protocols.
- Stay updated on industry trends, regulatory changes, and emerging quality standards in healthcare and medical research.
Qualifications
- Bachelorâs degree in Pharmacy, Medicine, Biology, Biochemistry, or a related field. Advanced degrees (Masterâs/PhD) are a plus.
- Minimum 3 years of experience in Quality Assurance, preferably within the healthcare, pharmaceutical, or medical research sectors.
- In-depth knowledge of GCP (Good Clinical Practice), GLP (Good Laboratory Practice), ISO standards, and other relevant regulatory frameworks.
- Strong analytical, problem-solving, and attention-to-detail skills with the ability to interpret complex data.
- Excellent written and verbal communication skills in English; proficiency in Indonesian is advantageous.
- Experience conducting internal/external audits and implementing corrective actions.
- Proficiency in quality management systems (QMS) and documentation tools.
- Ability to work independently and collaboratively in a fast-paced, multicultural environment.