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Open Positions: QA Supervisor & QC Analyst
Location: Cikarang
At PT Virtue Diagnostics Indonesia, we're at the forefront of developing in vitro diagnostic solutions that save lives. We're on the hunt for passionate individuals to join our quality assurance and control teams to ensure our products meet the highest standards.
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QA Supervisor
Key Responsibilities:
1. Develop and implement quality assurance policies and procedures.
2. Supervise daily QA activities and manage the QA team.
3. Ensure compliance with CPAKB, ISO 13485, IVDR, and other regulatory requirements.
4. Conduct internal audits, supplier audits and manage external audits.
5. Monitor new product development and technology transfer.
6. Monitor customer complaint, field safety corrective action (FSCA), and product recalls.
7. Lead continuous improvement initiatives to enhance product quality and efficiency.
Qualifications:
1. Bachelor’s degree in a scientific discipline.
2. 3+ years of QA experience in the in vitro diagnostics, medical device, or pharmaceutical industry.
3. Proven leadership skills and a deep understanding of regulatory requirements.
4. Excellent communication and teamwork skills.
5. Able to speak english actively.
_______________________________________________
QC Analyst
Key Responsibilities:
1. Conduct detailed analytical testing for raw materials, in-process materials, and finished products.
2. Participate in the validation and calibration of laboratory equipment and procedures.
3. Maintain accurate records of test results and prepare reports for management review.
4. Assist in the investigation of non-conformances and implementation of corrective actions.
5. Ensure compliance with all regulatory standards, including CPAKB, ISO 13485 and IVDR guidelines.
Qualifications:
1. Bachelor’s degree in Biology, Chemistry, Biochemistry, or a related field.
2. Preferably 1-2 years of experience in a QC role, ideally within the in vitro diagnostics or related regulated industry.
3. Strong analytical skills with attention to detail.
4. Familiarity with laboratory information systems and proficiency in data analysis.
Apply now
Send your resume and a cover letter detailing your relevant experience to fairus.zabadi@virtuedx.com by March, 31.
PT Virtue Diagnostics Indonesia is committed to diversity and inclusion. We welcome applicants of all backgrounds to join our quest to make the world a healthier place.
https://virtuedx.co.id/ | Global Innovation, Local Solution
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