Senior Quality Control Leader – Pharma & Medical Devices

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

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.