Senior Quality Assurance Staff

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

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

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 (www.cni.co.id).

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 (www.cni.co.id).

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.