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QC Manager
2 weeks ago
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
