更新日 2024-03-08
掲載開始日 2024-03-08

Site QA Specialist (Kanto) at Global Leading Biopharma

人材紹介
スタッフレベル

この求人の取扱い会社	マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.
企業名	会社名非公開
職種	メディカル/医薬/バイオ/素材/食品 - 品質管理/保証メディカル/医薬/バイオ/素材/食品 - 生産技術/生産管理メディカル/医薬/バイオ/素材/食品 - 製品開発
業種	製薬メーカー
勤務地	アジア日本東京都
仕事内容	Take lead in all support in the establishment of QMS as well as ensuring effective compliance at the company's site. Maintain all QA activities are aligned with GMP Description * Manage any local QC testing including packaging requirements to ensure specifications are correct * Maintain products are aligned with effective compliance * QA documents are following company SOPs with local standards * Manage site change control activities and self inspection as well as supplier audits * Execute investigation for quality issues such as complaints, deviations, and CAPA if necessary Profile * University degree in scientific or related environment * Background in the pharmaceutical, chemical, physical, or related industry * Experience in quality related work with GMP as well as GxPs * Understanding of local regulations compliance as well as being able participate in PMDA inspections * Pharmacist license preferred * High fluency in English and Japanese (non-native level speakers will not be selected) Job Offer * Competitive salaries and benefits * Great work life balance * International working environment * Work with industry leaders who are solving various unmet medical needs * Amazing career progression in QA Page Group Japan is acting as an Employment Agency in relation to this vacancy.
企業について（社風など）	* One of the top global biopharma companies in the industry * Rich development pipeline specializing in Oncology, Immunology, Immuno-Oncology, Fertility for unmet medical needs * New product launch almost every other year * Extensive communication with global HQ * Hybrid working style
英語能力	ビジネス会話 (TOEIC 735-860)
日本語能力	ネイティヴレベル
年収	日本・円 500万円〜 750万円