Senior QA Lead – Medical Devices & PKRT (QMS & Audit)

PT Sukses Abadi Farmindo; Tangerang; On-site; IDR 200,880,000 - 290,160,000; Full time

Job summary

PT Sukses Abadi Farmindo is seeking a Quality Assurance professional to manage the QMS for PKRT and medical device manufacturing in Indonesia, ensuring compliance with quality standards and regulatory requirements.

You will oversee change control, deviations, audits, document control, CAPA, calibration, and qualification activities, while collaborating with cross-functional teams to drive continuous improvement.

Qualifications

• Minimum Bachelor's Degree in Chemistry, Chemical Engineering, Pharmacy, or Pharmacist.
• Minimum 2 years of experience in Quality Assurance in manufacturing.
• Familiar with QMS and QA processes.
• Trained in ISO 9001/ ISO 14001/ ISO 45001 and related standards.
• Proficient with MS Office (Word and Excel).

Responsibilities

• Manage and maintain the Quality Management System (QMS) including Change Control, Deviation Reports, Customer Complaints, Audit, and Document Control.
• Organize and maintain QA documents and records for traceability and accessibility.
• Review and update controlled documents per requirements and procedures.
• Develop and monitor internal and external audit programs and schedules.
• Support audits with documentation and follow-up of findings.
• Monitor CAPA effectiveness from audits, deviations, complaints, and quality issues.
• Coordinate calibration activities (internal and external) according to schedules.
• Coordinate qualification and validation activities with proper documentation.
• Ensure QA activities align with SOPs, standards, and regulatory requirements.
• Collaborate with departments to implement corrective actions and continuous improvement.

Skills

Attention to detail

Documentation skills

Analytical thinking

Communication skills

Education

Bachelor's degree in Chemistry/Chemical Engineering/Pharmacy

Tools

Microsoft Word

Microsoft Excel

Job description

PT Sukses Abadi Farmindo is seeking a Quality Assurance professional to manage the QMS for PKRT and medical device manufacturing in Indonesia, ensuring compliance with quality standards and regulatory requirements.

You will oversee change control, deviations, audits, document control, CAPA, calibration, and qualification activities, while collaborating with cross-functional teams to drive continuous improvement.