Lokerpasuruan.com – Loker Cikarang Terbaru 2023 – Loker Cikarang Via Email – Lowongan Kerja Menarini Group Terbaru – We are member of globally company that has head office in Italy. We continues to build its reputation as a fully integrated biopharmaceutical company based on the illustrious history and success of the Group.
Loker Menarini Group Cikarang Terbaru
Saat ini Menarini Group sedang membuka Lowongan Kerja penempatan Cikarang untuk menempati Posisi sebagai.
Dibutuhkan Untuk Posisi :
- CMC Regulatory Officer
Kualifikasi :
Qualification:
· Bachelor degree in Pharmacy, Chemistry or any equivalent background
· Having experience minimum 1 year in Quality Assurance or Regulatory at Pharmaceutical Company
· Having knowledge related to product registration process and regulation, quality control and manufacturing
· Team player and able to communicate with related departments and/or third parties
· Proficient in English
· Willing to be placed in Cikarang
Job Description:
· In collaboration with involved Manufacturing functions and Regulatory Affairs, responsible for preparing registration dossiers for products marketed.
· Responsible for supporting Regulatory Affairs for new Registrations, variation and MAH renewal related to the Chemistry, Manufacturing and Controls of the product throughout its initial development and lifecycle.
· Proposing technical solutions to address regulatory requirements or deficiency letter from health authority.
· Responsible for evaluating Dossiers, classifying any non-conformities found and coordinating the activities of drafting the documentation in requesting the execution of operational activities (e.g. stability studies, method development and validation, process validation, etc.).
· Responsible for verifying of technical document to ensure compliance with standard (e.g ACTD, ICH, etc) as well as alignment with corporate or regional document.
· Responsible for managing Change Control for regulatory topics as Originator (management of regulatory impact due to change on API Supplier, Site Change etc.)
· Maintaining effective relationships with local & global partners, i.e., Product Development, Quality Assurance, Regulatory Affair, other related functions.
· Support site project by providing a correct and timely registration dossier
Informasi Tentang Menarini Group :
Kategori Lowongan Kerja : Layanan Kesehatan
Tipe Pekerjaan : Penuh Waktu
Penempatan : Cikarang
Gaji Menarini Group : –
