Remote Quality Assurance Specialist — GMP & Compliance

Jogjalowker; Kota Yogyakarta; Remote; IDR 905.141.000 - 1.448.226.000; Vollzeit

Benefits dieser Stelle

Health coverage (medical, dental, &amp

Home office stipend

Continuous learning opportunities

Equity potential

Zusammenfassung

Jogjalowker is seeking aQuality Assurance Specialist for a fully remote role to ensure all manufacturing processes and documents meet GMP/ISO standards. You will develop QA procedures, conduct audits, and drive regulatory compliance from any location.

The ideal candidate has at least 3 years of QA experience in pharma or medical devices, with strong analytical skills and the ability to work independently in a remote setting. Competitive benefits are provided.

Qualifikationen

• Bachelor's degree in Chemistry, Biology, Pharmacy, or a related field.
• Minimum of 3 years of QA experience in pharma or medical devices.
• Strong GMP knowledge and familiarity with FDA 21 CFR Part 210/211.
• Experience with audits, deviations, and CAPA management.
• Proficiency with quality management software and tools.

Aufgaben

• Develop, implement, and maintain QA protocols and SOPs.
• Conduct internal audits of processes, docs, and systems for compliance.
• Review and approve batch records, validation reports, and QA docs.
• Investigate deviations and customer complaints; implement CAPAs.
• Participate in external audits and regulatory inspections as needed.
• Monitor quality data, identify trends, and drive improvements.
• Ensure compliance with FDA regulations, ICH guidelines, and SOPs.
• Train personnel on QA procedures and best practices.
• Manage supplier quality agreements and conduct supplier audits.
• Contribute to ongoing QMS improvements.

Kenntnisse

Attention to detail

Analytical thinking

Independent work

Remote work capability

Ausbildung

Bachelor's degree in Chemistry, Biology, Pharmacy, or related field

Tools

QMS software

Jobbeschreibung

Jogjalowker is seeking aQuality Assurance Specialist for a fully remote role to ensure all manufacturing processes and documents meet GMP/ISO standards. You will develop QA procedures, conduct audits, and drive regulatory compliance from any location.

The ideal candidate has at least 3 years of QA experience in pharma or medical devices, with strong analytical skills and the ability to work independently in a remote setting. Competitive benefits are provided.