QC Manager

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Job Description

Duties & Responsibilities :

1.    Manage laboratory function, chemical and microbiologicaly 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 apropiateness 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.    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

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