Deskripsi Pekerjaan
Informasi lengkap tentang posisi dan persyaratan
Ringkasan Yukerja
Lowongan QA Compliance Staff di Taisho Pharmaceutical Indonesia kami kurasi dari JobStreet (kategori Teknologi & IT). Perhatikan lokasi kerja (Depok, West Java) sebelum melamar. Yukerja.com bukan pemberi kerja — lamaran diproses di situs sumber resmi.
QA Compliance Staff
Coordinate Change Control and CAPA implementation in accordance with approved SOPs, manage the e-CAPA system, facilitate Change Control activities, and support quality reporting and QA Compliance initiatives.
Accountabilities
Responsible for implementation of the Change Control procedure.
Responsible for implementation of the CAPA handling procedure.
Control and monitor CAPA fulfillment using the e-CAPA system for various triggers, for example: change request, deviation, event, planned action, audit, self-inspection, complaint, OOS report, PQR report, Validation Report, and Qualification Report.
Prepare Quality reporting monthly, for example: QO monthly report, Quality council report, ITO report, and TPI-TPJ monthly report.
Support in execution of various projects in QA Compliance section.
Education Requirements
Bachelor’s degree in pharmacy or pharmacist
Experience Requirements
Have a minimum 3 - 5 years, preferably having experience in the pharmaceutical industry in the QA area.
Understand basic principles of GMP/CPOB, Good Documentation Practice, and Data Integrity.
Understand Change Control Management and CAPA Management, preferably having experience handling Change Control and CAPA.
Have good analytical thinking
Have good communication skills
Have a good command of computers.