◆業務内容
品質管理部における分析機器を使用した原薬の試験検査等の品質管理業務
~日本薬局方にしたがった試験が主となります。
◎詳紙
・原菓の品質試験の実施及び記録の確認
OOS、逸脱管理及び変更管理などの品質システムへの対応
・新規原薬承認のための規格・試験法の設定や分析バリデーションの実施
・将来的には部内のマネジメント・人的管理を担う
~これらに付随する業務全般
・液体高速クロマトグラフ装置IHPLC)・ガスクロマトグラフ装置(GC)
・紫外可視吸光度計(UV、VIS)
・旋光度計
・赤外吸収スペクトル計(FT-IR)
・融点測定装置
・水分測定装置(カールフィッシャー法)・その他、一般的を理化学機器
・その他、一般的を理化学機器
※変更の範囲:会社の定める業務(その他詳細は面談でお伝えします)
【求める人材】
【求める人物像】
・医業品原薬商社として品質試験を実施することで製品の品質を保証するための品質管理の知識や経験が豊富で、品質重視の観点から会社の発展のために邁進できる方
・チームをリードするマネジメント能力を備えだ方
【必須要件】
・薬学または化学のパックグランドをお持ちの方
・GMPに適合した製造所での勤務経談のある方
・品質管理業務(試験の実施や試験室の管理)の業務経験がある方
(実務経験5年以上)
・海外公定書やCTD の内容を理解できる英語力を備えだ方
【歓迎要件】
・規格・試験法の設定や分析バリデーションの経験のある方
・業務調整のための部内外、社外とのコミュニケーションが良好に
取れる方
・品質管理部門での管理職経験がある方
(マネジメント経験3年以上)
(その他詳細は面談でお伝えします)
【給与】
750~850万円
【勤務地】
東京都
【勤務時間】
求人紹介時に詳しくお伝えいたします。
【雇用・契約形態】
正社員
【待遇・福利厚生】
その他制度
【休日・休暇】
年末年始休暇/夏季休暇/有給休暇/慶弔休暇/創立記念日/完全週休2日制(土・日)
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