QA Inspector

PT Oneject Indonesia; Desa Ciranjeng; On-site; IDR 78,120,000 - 122,760,000; Full time

Job summary

PT. Oneject Indonesia is a medical devices manufacturer producing Auto Disable Syringes. The QA role requires at least 1 year of QA experience in the medical device or pharmaceutical industry and familiarity with validation, qualification, calibration, CAPA, and change control procedures.

Candidate must be able to work in shifts and be willing to be stationed at KITIC Cikarang, supporting ISO 13485:2016 processes and the QC/R&D collaboration to maintain product quality.

Qualifications

• Minimum SMK in Pharmacy, Chemistry, Industrial Chemistry, or related major.
• Minimum 1 year of experience in QA, preferably in medical device or pharmaceutical industry.
• Familiar with Validation, Qualification, and Calibration processes, including preparation of protocols, reports, and implementation schedules.
• Familiar with CAPA, Change Control, SOP, and Work Instruction (WI) implementation.
• Basic understanding of Quality Management System and ISO 13485:2016.
• Strong analytical, problem-solving, documentation, and attention-to-detail skills.
• Able to coordinate and collaborate effectively with cross-functional teams.
• Willing to work in shifting working hours.
• Willing to be placed in KITIC Cikarang.

Skills

QA experience

Cross-functional collaboration

Education

SMK in Pharmacy/Chemistry/Industrial Chemistry

Tools

Validation

Qualification

Calibration

CAPA

Change Control

SOP

Work Instructions

Job description

Minimum Vocational High School (SMK) in Pharmacy, Chemistry, Industrial Chemistry, or related major

Minimum 1 year of experience in Quality Assurance (QA), preferably in medical device or pharmaceutical industry

Familiar with Validation, Qualification, and Calibration processes, including preparation of protocols, reports, and implementation schedules

Familiar with CAPA, Change Control, SOP, and Work Instruction (WI) implementation

Basic understanding of Quality Management System and ISO 13485:2016

Strong analytical, problem-solving, documentation, and attention-to-detail skills

Able to coordinate and collaborate effectively with cross-functional teams

Willing to work in shifting working hours

Willing to be placed in KITIC Cikarang

Pharmaceuticals, Biotechnology & Medical Devices Not specified

PT. Oneject Indonesia is a Medical Devices manufacturer produces Auto Disable Syringes.

As a pioneer of AD syringes manufacturer in Indonesia in providing safe injections, PT. Oneject Indonesia has contributed to reduce the number of standard syringes, which are produced and distributed in Indonesia. Our product is the market leader of AD syringes in Indonesia with 90% market share.

PT. Oneject Indonesia is growing continuously, not only in Indonesia. We have been exported our AD syringes to Asian countries and ready to enter the European market. We ensure the quality of the products at each stage of the production process starting with the selection of medical grade raw materials, the complete manufacturing process to the point of finished product. The products are monitored and controlled by our QC Department as per requirement of ISO 9001:2015 and ISO 13485:2016, in cooperation with our R&D Department, in order to continuously monitor the improvement, innovation and thereby increase our product quality.

PT. Oneject Indonesia is a Medical Devices manufacturer produces Auto Disable Syringes.

As a pioneer of AD syringes manufacturer in Indonesia in providing safe injections, PT. Oneject Indonesia has contributed to reduce the number of standard syringes, which are produced and distributed in Indonesia. Our product is the market leader of AD syringes in Indonesia with 90% market share.

PT. Oneject Indonesia is growing continuously, not only in Indonesia. We have been exported our AD syringes to Asian countries and ready to enter the European market. We ensure the quality of the products at each stage of the production process starting with the selection of medical grade raw materials, the complete manufacturing process to the point of finished product. The products are monitored and controlled by our QC Department as per requirement of ISO 9001:2015 and ISO 13485:2016, in cooperation with our R&D Department, in order to continuously monitor the improvement, innovation and thereby increase our product quality.