Job description for Senior Quality Assurance Staff at PT Sukses Abadi Farmindo
About the role
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, ISO19001, 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.
