Quality Section Head (supervisor)

PT Oneject Indonesia; Desa Ciranjeng; On-site; IDR 260,000,000 - 420,000,000; Full time

Job summary

PT Oneject Indonesia, a leading medical devices manufacturer of Auto Disable Syringes, is seeking a QA/QC Leader to drive quality assurance and regulatory compliance. The role requires a strong background in QMS, CAPA, audits, and documentation, with English proficiency and team leadership.

The position is based in KITIC Cikarang, Indonesia. The ideal candidate will have 3+ years in QA/QC or 1+ year as Quality Section Head in a medical device setting, and will manage documentation,

Qualifications

• Bachelor Degree in Pharmacy, Chemical, or Industrial Engineering.
• Minimum 3 years QA/QC experience or 1+ year as Quality Section Head in medical devices.
• Strong knowledge of QMS and regulatory standards; ISO 9001 and ISO 13485 familiarity.
• Excellent English communication, both written and spoken.
• Ability to lead a team, assign tasks, monitor performance and ensure procedure compliance.
• Willing to be stationed at KITIC Cikarang; based in Indonesia.

Responsibilities

• Lead the QA/QC department to ensure product quality and regulatory compliance.
• Maintain and update documentation related to compliance, CAPA, Change Control, and audits.
• Review circulating documents; monitor documentation systems; establish SOPs/WIs.
• Provide investigation reports and oversee quality control testing and analysis.
• Ensure GMP/ISO compliance across all manufacturing and QC activities.

Skills

QA/QC

CAPA

Audit

Documentation

ISO 9001

ISO 13485

Leadership

English

Education

Bachelor Degree in Pharmacy / Chemical / Industrial Engineering

Tools

Laboratory testing

Job description

Bachelor Degree from majoring in Pharmacy / Chemical / Industrial Engineering

Having minimum 3 years of working experience in QA/QC Activities or minimum 1 years of working experience as Quality Section Head (Supervisor) from medical device manufacturer would be an advantage

Good understanding of QMS ; Maintain documentation related to compliance and ensure it comply with regulations and standards; Maintain compliance master list document, CAPA, Change Control, Audit, customer complaints ; review circulation documents ; monitoring documentation system ; establish procedure (SOP / WI) related ; Provide investigation reports ; Quality Control management ; Familiar with Laboratory testing & analysis ; ISO/GMP understanding

Good communication in English both written or verbal is mandatory

Demonstrated ability to lead a team, assign tasks, monitor performance, and ensure compliance with procedures

Strong analytical, problem solving skills and attention to detail

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.

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.