QA GxP System Officer

Bayer | Depok | ID

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To support QA GxP System Associate Manager and as Qualification lead with main focus on GMP Relevant of Technical System lifecycle and calibration review ...

QA GxP System Officer





JOB PURPOSE


  • To support QA GxP System Associate Manager and as Qualification lead with main focus on GMP Relevant of Technical System lifecycle and calibration review, including qualification activities according to new installation, modification, and relocation issue.

YOUR TASKS AND RESPONSIBILITIES


  • Coordinate the Technical System lifecycle are implemented according to the updated SOP.
  • Preparing related document about Qualification activities (e.g. Qualification Plan, Qualification Protocol, and Qualification Report) according to the respective SOP.
  • Coordinate with other department (e.g. Engineering, Project, Quality, Operations, Supply Chain Management (SCM), Health Safety and Environment (HSE), and Technical Supply Management (TSM) that has Technical System issue, such as new installation / modification / relocation / retirement. And also coordinate with project lead related vendor schedule.
  • Execute qualification activities that has been scheduled with timely manner.
  • Monitor and control the calibration schedule in Cimanggis and ensure there are no overdue or uncalibrated status in critical parameter of technical system.
  • Conduct review calibration report and create tag calibration status.
  • Perform evaluation/investigation of deviations results related with the qualification issue.
  • Create and/or review of procedures (e.g. SOPs and templates) related to technical system lifecycle topic to ensure the procedures are aligned with the updated requirement (e.g.: CMS (Bayer Regulation: GOI, GSOP, Supplement, Best Practices, Local regulation such as CPOB, PICs, HALAL, SMK3).
  • Follow up the CAPA recommendation from qualification activities in Dev@com System and ensure the CAPA recommendation from qualifications are closed timely manner.
  • Follow up the CAPA recommendation from event/deviation/risk assessment in Dev@com system and ensure the CAPA recommendation are closed timely manner
  • Educate related person who relevant with qualification activities.
  • As a proxy of QA GxP System Associate Manager if the Supervisor is not available.
  • Support maintaining appropriate precaution on occupational safety and health as well as security of facilities within Quality Department.

WHO YOU ARE


  • Bachelor degree in Pharmacy / Apothecary / Chemical Engineering / Industrial Engineering or related area.
  • Fresh graduate/Having 1+ experience in GMP aspects related with food supplement or drug manufacturing/fresh graduate is still applicable.
  • Having knowledge related with the qualification activities requirements.
  • Having knowledge related with the manufacturing, packaging, and cleaning validations requirements.
  • Having knowledge related with the computerized system validations requirements.
  • Having knowledge on international and local GMP principles for manufacturing of pharmaceutical products and Food supplements and Halal Management System.
  • Skilled to work within an international team and ability to work within teams.
  • Good English skills.
  • Having high motivation to learn a new thing.
  • Having good writing and communication skill both in English and Bahasa




Application Period: 6 - 19 February 2024 Reference Code: 811766
Division: Consumer Health Location: Indonesia : West Java : Cimanggis
Functional Area: Quality Position Grade: R09
Employment Type: Contractual Work Time: Flexi Hours - 8 working hours



Contact Us

Address Telephone E-Mail
PT Bayer Indonesia
Menara Astra, 33rd floor
Jl. Jend. Sudirman Kav.5-6, Jakarta 10220, Indonesia

+622130491111

recruitment.indonesia@bayer.com

Informasi Tambahan :

  • Perusahaan : Bayer
  • Posisi : QA GxP System Officer
  • Lokasi : Depok
  • Negara : ID

Cara Mengirimkan Lamaran :

Setelah Membaca dan telah mengetahui kriteria dan kebutuhan minimum kualifikasi yang telah dijelaskan dari info pekerjaan QA GxP System Officer di kota Depok diatas dengan demikian jobseeker yang merasa belum memenuhi persyaratan meliputi pendidikan, umur, dll dan memang merasa berminat dengan lowongan kerja terbaru QA GxP System Officer, pada bulan ini 2024 diatas, hendaknya secepatnya untuk melengkapi dan menyusun berkas lamaran kerja seperti surat lamaran kerja, CV atau daftar riwayat hidup, FC ijazah dan transkrip dan pelengkap lainnya seperti yang telah dijelaskan diatas, guna mendaftar dan mengikuti seleksi masuk penerimaan pegawai baru diperusahaan yang dimaksud, dikirim melalui link Halaman Selanjutnya di bawah ini.

Proses Selanjutnya

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Tanggal Tayang : 15-02-2024