QC Manager

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 employment application is true to the best of my knowledge.

Job Description:

Duties & Responsibilities :

• Manage laboratory function, chemical and microbiologicaly testing, environment monitoring; and manage
  
  

laboratory instrument calibration and qualification.

• 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.

• Ensure QC activities comply with Good Laboratory Practice guideline.
• Manage testing of incoming material, bulk, intermediate, finished product, stability samples, and complaint
  
  

products as appropriate.

• 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.

• Ensure management of reagent and reference standards in accordance with GMP and Takeda SOP.
• Management of reference and retention sample of material and product.
• Manage QC budget (Opex, Project budget and QC CAPEX) and control the budget accordingly.
• Maintaining of Quality Management Master Data in SAP system (optional SAP key users).
• Verify testing report, ensure data integrity and conformity with analytical procedure, compare to establish
  
  

specifications, and make recommendations on apropiateness of data for release.

• Disposition of incoming raw material and packaging material.
• Manage lab investigation. Ensure quality of investigation, timely closure and KPI are met.
• 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.

• 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.

• As Proxy of Site Quality Head as needed.
• Actively participate with programs/projects/initiative in the Plant (Agile, Lab Excellence, etc.)
• Active and responsible for running EHS programs relevant for QC and site as applicable.
• Ensure laboratory arrangement (5S) are maintained properly
  
  

Locations:

Bekasi, Indonesia

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time