Quality Control Manager

PT Oneject Indonesia; Desa Ciranjeng; On-site; IDR 300,000,000 - 540,000,000; Full time

Job summary

PT Oneject Indonesia in Cikarang is seeking an experienced QC Manager to lead our QC team across incoming materials, IPC, and finished product testing, ensuring compliance with specifications.

You will implement GMP, GLP, analytical methods, and testing procedures, drive continuous improvement, manage resources, and collaborate with QA, Production, and Engineering to maintain ISO 9001:2015 and ISO 13485:2016 standards.

Qualifications

• Bachelor’s degree in Pharmacy, Chemical Engineering, Industrial Engineering, Chemistry, Health Sciences, or related field.
• Minimum of 10 years of experience in quality control in the pharmaceutical or medical device industry.
• Communicative in English communication both verbal and written.

Responsibilities

• Oversee QC activities, including incoming material inspection, in-process control (IPC), and finished product testing, ensuring compliance with established specifications and quality standards.
• Ensure the implementation of Good Laboratory Practices, analytical methods, testing procedures, and applicable quality standards, while monitoring testing performance, capacity, workload, and turnaround time.
• Lead the investigation and resolution of Out of Specification results and quality issues, and drive continuous improvement within QC operations.
• Manage QC manpower, competency development, laboratory capacity, CAPEX, and OPEX to ensure effective resource utilization and operational efficiency.
• Ensure Quality Management System and regulatory compliance within QC, and collaborate with QA, Production, Engineering, and other relevant functions to address quality issues and support continuous improvement.

Skills

English communication

Leadership

Education

Bachelor in Pharmacy/Engineering

Tools

Microsoft Office

Job description

Bachelor’s degree in Pharmacy, Chemical Engineering, Industrial Engineering, Chemistry, Health Sciences, or related field.

Minimum of 10 years of experience in quality control in the pharmaceutical or medical device industry.

Communicative in English communication both verbal and written

Good leadership skill & Proficient in Microsoft Office

Willing to be placed in KITIC - Cikarang

Responsibilities :

Oversee QC activities, including incoming material inspection, in-process control (IPC), and finished product testing, ensuring compliance with established specifications and quality standards.

Ensure the implementation of Good Laboratory Practices, analytical methods, testing procedures, and applicable quality standards, while monitoring testing performance, capacity, workload, and turnaround time.

Lead the investigation and resolution of Out of Specification results and quality issues, and drive continuous improvement within QC operations.

Manage QC manpower, competency development, laboratory capacity, CAPEX, and OPEX to ensure effective resource utilization and operational efficiency.

Ensure Quality Management System and regulatory compliance within QC, and collaborate with QA, Production, Engineering, and other relevant functions to address quality issues and support continuous improvement.

Note :

Only shortlisted candidates will be contacted

Recruitment is free of charge. PT Oneject Indonesia will never request any fees, deposits, or payments from candidates throughout the recruitment process

Unlock job insights

Hirer responsiveness Salary match Number of applicants

Your application will include the following questions:

• Berapa gaji bulanan yang kamu inginkan?
• Kualifikasi mana yang kamu miliki?
• Bagaimana kamu menilai kemampuan bahasa Inggrismu?

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 is 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.

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