Staff QA

PT Sukses Abadi Farmindo; Cikupa; On-site; IDR 167,400,000 - 256,680,000; Full time

Job summary

PT. Sukes Abadi Farmindo is seeking a QA-focused professional in Indonesia with a minimum of 1 year in manufacturing of medical equipment or health supplies. The role emphasizes calibration, qualification, and validation, along with ISO 9001/14001/45001 knowledge and SOP adherence.

The candidate will support QMS activities, audits, and continuous improvement initiatives, coordinating with multiple departments to ensure robust quality processes.

Qualifications

• Bachelor degree in relevant field (S1) required.
• At least 1 year in manufacturing of medical equipment or health supplies.
• Knowledge of calibration, qualification, and validation methods.
• Familiar with ISO 9001/14001/45001 and related SOPs.

Responsibilities

• Develop schedules for internal and external calibration, qualification, master validation plans, and environmental monitoring.
• Manage and maintain the QMS, including change control, audits, deviation management, customer complaints, and document control.
• Support audits with preparation, documentation, and follow-up of findings.
• Maintain QA documentation and records.
• Coordinate calibration, qualification, validation, and environmental monitoring activities per procedures.
• Collaborate with departments to implement quality procedures and continuous improvement.

Skills

Calibration

Qualification

Validation

QMS knowledge

Auditing (internal)

Education

Bachelor's degree (S1) in Chemistry / Chemical Engineering / Pharmacy

Job description

Minimum Bachelor Degree (S1) in Chemistry, Chemical Engineering & Pharmacy

Minimum 1 year of experience in the same field/ manufacturing of medical equipment/ Household Health Supplies

Knowledge of calibration, qualification, and validation methods and operations

Understanding and certificatio of ISO 9001, 14001, 45001, SOPH, calibration.

Key responsibilities

Develop schedules for internal calibration, external calibration, qualification, master validation plans, and environmental monitoring

Manage and maintain the Quality Management System (QMS), including change control, audit, deviation management, customer complaints, and document control

Support internal and external audits, including audit preparation, documentation, and follow-up of findings

Manage and maintain QA documentation and records.

Coordinate and monitor calibration, qualification, validation, and environmental monitoring activities according to established schedules and procedures

Collaborate with relevant departments to implement quality procedures, corrective actions, and continuous improvement initiatives

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.