QC Manager

Job Description

Duties & Responsibilities :

• Manage laboratory function, chemical and microbiological 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 applicability 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.

Bekasi, Indonesia

Employee

Regular

Full time