Deskripsi Pekerjaan

COMPANY CATEGORY :  Japanese Medical Equipment Manufacturing   JOB SUMMARY :  Compilation data related Quality Coordinate for regulatory/registration process (all domestic and overseas) Manage and direct a team of skilled, semi skilled and technically individuals To manage Regulatory Affair, QMS ISO 13485, Risk Management Plan/RMP, Clinical Evaluation, REACH, Verification & Validation, Calibration, Audit (Regulatory, Customer, Supplier, and Internal), Corrective and Preventive Action/CAPA, Complaint Handling, Product Release, Device History Record/ DHR, Change Control, Monthly meeting, Management review meeting, Design History File/DHF   EXPERIENCE, REQUIREMENTS & SKILLS :  Education: Bachelor Degree Chemical/Pharmacy/Biology major Language: English Intermediate Level Experience: 5 years in medical device/ Pharmaceutical/FMCG manufacturing Experience in concept of CPAKB, GMP Must have capabilities: Leadership, Project Management, Performance Evaluation, Analytical thinking, Independent, Judgment. Preferably Assistant manager/senior supervisor specialized in manufacturing Quality Assurance/Control or equivalent   BENEFIT: THR BPJS Meal Transportation Detail will be discussed in the interview   ONLY CV IN ENGLISH WILL BE PROCESSED

Tentang Perusahaan

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