QC Manager

PT Takeda Indonesia; Bekasi; On-site; IDR 666.777.000 - 1.000.167.000; Full time

Job summary

A leading pharmaceutical company in Bekasi, Indonesia, is seeking a candidate for a full-time position. The role involves managing laboratory functions, ensuring compliance with regulatory requirements, overseeing testing procedures, and maintaining quality management documentation. The ideal candidate will have experience in laboratory management and a robust understanding of Good Laboratory Practices. This position also requires strong leadership skills to motivate and guide team members toward quality mindset behaviors.

Qualifications

• Proven record in managing laboratory functions and testing.
• Good understanding of regulatory requirements related to QC activities.
• Experience with analytical method validation and verifying testing reports.

Responsibilities

• Manage laboratory functions and compliance with health authority regulations.
• Ensure laboratory activities adhere to Good Laboratory Practices.
• Oversee testing of incoming materials and finished products.
• Manage QC budget and maintain quality management data.

Skills

Laboratory management

Chemical testing

Microbiological testing

Regulatory compliance

Good Laboratory Practice

Data integrity

People management

Tools

SAP

Job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my application is true to the best of my knowledge.

Job Description

Based on the corporate philosophy of “Takeda-ism” (Integrity: Fairness, Honesty and Perseverance) developed over its long corporate history of more than 230 years, Takeda conducts activities according to the corporate mission to “strive towards better health for people worldwide through leading innovation in medicine.” PT. Takeda Indonesia is looking for a potential candidate to join our team.

1. Manage laboratory function, chemical and microbiological testing, environment monitoring; and manage laboratory instrument calibration and qualification.
2. Ensure QC activities complies with regulatory requirements from the health authority (BPOM, Kementerian Kesehatan) and ensure regulatory reporting related with QC activities are performed accordingly.
3. Ensure QC activities comply with Good Laboratory Practice guideline.
4. Manage testing of incoming material, bulk, intermediate, finished product, stability samples, and complaint products as appropriate.
5. Manage analytical method transfer/verification/validation, take part in validation program, manage testing of validation samples received or taken according to the existing testing procedure.
6. Ensure management of reagent and reference standards in accordance with GMP and Takeda SOP.
7. Management of reference and retention sample of material and product.
8. Manage QC budget (Opex, Project budget and QC CAPEX) and control the budget accordingly.
9. Maintaining of Quality Management Master Data in SAP system (optional: SAP key users).
10. Verify testing report, ensure data integrity and conformity with analytical procedure, compare to establish specifications, and make recommendations on appropriateness of data for release.
11. Disposition of incoming raw material and packaging material.
12. Manage lab investigation. Ensure quality of investigation, timely closure and KPI are met.
13. Manage documentation, including establishing and update of QC SOPs and specification for material inspection, test and analysis, sampling plans, sampling procedures, and maintain testing records.
14. People management: motivate organization team members to habitually demonstrate consistent Quality Mindset Behavior by lead by example, create a team environment where individuals feels motivated, provide regular & constructive feedback to team and coaching where necessary.
15. Act as Proxy of Site Quality Head as needed.
16. Actively participate with programs/projects/initiative in the Plant (Agile, Lab Excellence, etc.).
17. Active and responsible for running EHS programs relevant for QC and site as applicable.
18. Ensure laboratory arrangement (5S) are maintained properly.

Location & Employment Details

Location: Bekasi, Indonesia

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time

Pharmaceuticals, Biotechnology & Medical 101-1,000 employees