Senior Quality Assurance
Listed on 2026-09-21
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Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers, Quality Engineering
This is a Quality Assurance role in medical device or Household Health Supplies (PKRT) manufacturing, responsible for managing and maintaining the Quality Management System (QMS) and ensuring compliance with quality standards and regulatory requirements.
Key responsibilities
Manage and maintain the Quality Management System (QMS), including Change Control, Deviation Reports, Customer Complaints, Audit, and Document Control
Organize and maintain physical and digital QA documents and records to ensure proper filing, traceability, and accessibility
Review and update controlled documents periodically in accordance with applicable requirements and company procedures
Develop and monitor the internal and external audit program and schedule
Support the preparation and implementation of internal and external audits, including documentation and follow-up of audit findings
Monitor the implementation and effectiveness of CAPA resulting from audit findings, deviations, customer complaints, and other quality issues
Coordinate and monitor calibration activities, including internal and external calibration, according to established schedules
Coordinate and monitor qualification and validation activities and ensure proper documentation
Ensure QA activities are implemented in accordance with established SOPs, quality standards, and applicable regulatory requirements
Collaborate with relevant departments to implement corrective actions and continuous improvement initiatives
About you
Minimum Bachelor's Degree (S1) in Chemistry, Chemical Engineering, Pharmacy, or Pharmacist
Minimum 2 years of experience in Quality Assurance, preferably in medical device or Household Health Supplies (PKRT) manufacturing
Familiar with Quality Management System (QMS) and quality assurance processes
Has received training in ISO 9001, ISO 14001, ISO 45001, ISO
19001, SJPH, Calibration, CPPKRTB, and CPAKB
Good understanding of Change Control, Deviation Report, Audit, Customer Complaint, Document Control, Calibration, and Validation
Proficient in Microsoft Office, particularly Microsoft Word and Excel
Strong attention to detail, documentation skills, analytical thinking, and good communication skills
Able to work independently and collaborate effectively with cross-functional teams
Pharmaceuticals, Biotechnology & Medical Devices 101-1,000 employees
PT. SUKSES ABADI FARMINDO
PT. Sukses Abadi Farmindo is subsidiary and manufacturing site of PT. Citra Nusa Insan Cemerlang ().
PT. Sukses Abadi Farmindo is a company engaged in manufacturing especially in OEM / ODM/ Personal Brand service for Food and Beverage, Food Supplements and Pharmaceutical products.
PT. SUKSES ABADI FARMINDO
PT. Sukses Abadi Farmindo is subsidiary and manufacturing site of PT. Citra Nusa Insan Cemerlang ().
PT. Sukses Abadi Farmindo is a company engaged in manufacturing especially in OEM / ODM/ Personal Brand service for Food and Beverage, Food Supplements and Pharmaceutical products.
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