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Lowongan Kerja QA Officer Pharma Metric Labs di Pharma Metric Labs Full Time Job

11 bulan yang lalu Pekerjaan Umum Jakarta   74 views
Job Details

JOB SPECIFICATION

  • Candidate must possess at least Bachelor's Degree in Biology, Chemistry, Pharmacy/Pharmacology or equivalent.
  • Required language(s): English
  • At least 3 Year(s) of working experience in BA/BE Lab / Clinical Research Organization is required for this position.
  • Required Skill(s): Good Laboratory Practice, Good Clinical Practice, Risk Management, System Management
  • Preferably Supervisor/Coordinator specialized in Healthcare - Pharmacy or equivalent.
  • Interest in system management and documentation.

JOB DESCRIPTION

  • Responsible for ensuring clinical and analytical studies are conducted in accordance with existing guidelines and regulations. Develops, performs, and manages quality programs. Actively lead or assist activities in the areas of internal quality audits, CAPA (Corrective and Preventive Actions), and Quality Audits.
  • Organize and implement Quality Programs in order to ensure compliance towards Standard Operating Procedure (SOP) and regulatory standards.
  • Manage internal and external audits and regulatory inspections.
  • Assist activities in the areas of CAPA (Corrective and Preventive Actions) and Quality Audits for specific studies.
  • Assist in providing training or Lessons Learned Sessions.
  • Assist conducting vendor and subcontractor audits.
  • Develop QA budget plan annually.
  • Ensure management review is conducted annually.
Deskripsi Perusahaan
Pharma Metric Labs is an independent Contract Research Organization (CRO), providing Clinical Study Management services, Bioavailability / Bioequivalence (BA/BE) Study and clinical trial for pharmaceutical company in Indonesia and ASEAN.
Lokasi :
Jl. Letjend. Suprapto No. 60 Cempaka Putih - Jakarta Pusat 10520.