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Manager, Quality Assurance, Investigational Medicinal Products Pipeline Development, Shonan iPark / 湘南アイパーク 治験薬品質保証‐開発担当 課長代理

Takeda
Full-time
Remote friendly (United States)
United States
Operations

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Role Summary

Responsibilities

  • ÈñãÁô∫„Éó„É≠„Ç∞„É©„Ɇ„ÅÆGMPÈÅµÂÆàÁä∂Ê≥ńůÁõ£Ë¶ñ
  • ÈñãÁô∫ÊñπÈáù„Å´ÂØæ„Åô„ÇãÂìÅË≥™‰øùË®ºÈÉ®ÈñÄ„ÅÆË¶ñÁÇπ„Åã„Çâ„ÅÆÊèêË®Ä
  • Ë£ΩÈĆÊñπÊ≥ï„ɪ˩¶È®ìÊñπÊ≥ï„ÅÆÊâøË™ç
  • Ê≤ªÈ®ìËñ¨Âá∫Ëç∑ÔºàË£ΩÈĆˮòÈå≤ÁÖßÊüª„ÇíÂê´„ÇÄÔºâ
  • Ê≤ªÈ®ìËñ¨Ë£ΩÈÄŴ„Åä„Åë„Çã§âÊõ¥ÁưÁêÜ
  • Ê≤ªÈ®ìËñ¨Ë£ΩÈÄŴ„Åä„Åë„ÇãÈÄ∏Ëѱ„ɪOOS/OOT„ɪËã¶ÊÉÖ„ÅÆË™øÊüª
  • „ǵ„Éó„É©„ǧ„ɧ„ɺ„Å´ÂØæ„Åô„ÇãGMPÁõ£Êüª„Å™„Çâ„Å≥„Å´ÂìÅË≥™Â•ëÁ¥Ñ„ÅÆÁ∑†Áµê
  • Á∂ôÁ∂öÁöфřÂìÅË≥™„Ç∑„Çπ„É܄Ɇ„ÅÆÊîπÂñÑ

Qualifications

  • Â≠¶Ê≠¥Ôºö§ßÂç퉪•‰∏ä„Åß„ÄÅËñ¨Â≠¶„ÄÅÂåñÂ≠¶„ÄÅÁîüÁâ©Â≠¶„ÄÅÂ∑•Â≠¶„Äńſ„Åü„ÅØÈñ¢ÈÄ£„Åô„ÇãÁßëÂ≠¶ÂàÜÈáé„ÅÆÂ≠¶Â£´Âè∑„ÇíÊúâ„Åô„ÇãÊñπ„Älj∏äÁ¥öÂ≠¶‰ΩçÔºàMS„ÄÅPhD„ÄÅPharmDÔºâ„ÇíÂèñÂæó„Åó„Ŷ„ÅÑ„Çã„Å®„Å™„ÅäËâØ„ÅÑ„ÄÇ
  • ÂÆüÂãôÁµåÈ®ìÔºö‰∏ãË®òÊ•≠Âãô„ÅÆ„ÅÑ„Åö„Çå„Åã„Å´„ŧ„ÅфŶ8Â𥉪•‰∏ä„Åæ„Åü„ÅØÂêåÁ≠â„ÅÆÁµåÈ®ì„Åå„ÅÇ„ÇãÊñπ
    • Ê≤ªÈ®ìËñ¨(ÂéüËñ¨„ɪˣΩÂâ§)„ÅÆÈñãÁô∫„Å™„Çâ„Å≥„Å´Ë£ΩÈÄŴÈñ¢„Åô„ÇãÂìÅË≥™‰øùË®ºÊ•≠Âãô
    • Ê≤ªÈ®ìËñ¨(ÂéüËñ¨„ɪˣΩÂâ§)„ÅÆË£ΩÈĆÊ≥ïÈñãÁô∫„ÇÇ„Åó„Åè„ÅØË©¶È®ìÊ≥ïÈñãÁô∫Ê•≠Âãô
    • ÂåªËñ¨Âìńſ„Åü„ÅØÊ≤ªÈ®ìËñ¨„ÅÆË£ΩÈĆ„ÇÇ„Åó„Åè„ÅØË©¶È®ìÊ•≠Âãô
  • Â∞ÇÈñÄÊÄßÔºöÂøÖ˶ńřÁü•Ë≠ò
    • ÂåªËñ¨ÂìÅ„ÅÆË£ΩÈĆÊ≥ïÈñãÁô∫„Åæ„Åü„ÅØË©¶È®ìÊ≥ïÈñãÁô∫„Å´Èñ¢„Åô„ÇãÁü•Ë≠ò
    • ÂåªËñ¨ÂìÅ„ÅÆË£ΩÈÄſ„Åü„ÅØË©¶È®ì„Å´Èñ¢„Åô„ÇãÁü•Ë≠ò
    • ÂåªËñ¨ÂìÅË£ΩÈÄŴ„Åä„Åë„ÇãÊúÄÊñ∞„ÅÆGMP˶ʼnª∂„Å®„Ǩ„ǧ„ÉÄ„É≥„Çπ„Å´Èñ¢„Åô„ÇãÁü•Ë≠ò
    • ÂïèȰå„Çí‰∫àÊ∏¨„Åó„ÄÅËߣʱ∫Á≠ñ„ÇíÁ©çÊ•µÁöфŴÊèêʰà„ÉªÂÆü˰å„Åô„ÇãËÉΩÂäõ
    • ˧áÈõë„Å™ÂïèȰå„ÇíÊ≠£„Åó„ÅèÁêÜËߣ„Åó„ÄÅȰïÂú®Âåñ„Åó„Ŷ„ÅÑ„Çã„Åæ„Åü„ÅØÊΩúÂú®Áöфř„É™„Çπ„ÇØ„ÇíÁâπÂÆö„ɪËߣÊ∂à„Åô„ÇãËÉΩÂäõ
    • Âõ∞Èõ£„Å´Èöõ„Åó„ŶÂà©ÂÆ≥Èñ¢‰øÇËÄÖ„Å®‰∫§Ê∏â„Åó„ÄÅÁõ∏‰∫í„Å´ÊúâÁõä„Å™Ëߣʱ∫Á≠ñ„Å´Âà∞ÈÅî„Åô„ÇãËÉΩÂäõ
  • Ë™ûÂ≠¶ÔºöËã±Ë™ûÔºö„Éì„Ç∏„Éç„Çπ„ɨ„Éô„É´„ÅÆ„Ç≥„Éü„É•„Éã„DZ„ɺ„Ç∑„Éß„É≥ËÉΩÂäõ
  • „Åù„ÅÆ‰ªñÔºö„Éè„ǧ„Éñ„É™„ÉÉ„Éâ„ɪ„ÉØ„ɺ„Ç≠„É≥„Ç∞„ɪ„É¢„Éá„É´„ÄÅÂõΩÂÜÖÂá∫ºµ„ÅÇ„Çä

Education

  • Â≠¶Â£´Âè∑ÔºàËñ¨Â≠¶„ÄÅÂåñÂ≠¶„ÄÅÁîüÁâ©Â≠¶„ÄÅÂ∑•Â≠¶„ÄÅÈñ¢ÈÄ£ÂàÜÈáéÔºâ
  • ‰∏äÁ¥öÂ≠¶‰ΩçÔºàMS„ÄÅPhD„ÄÅPharmDÔºâÊ≠ìËøé

Skills

  • GMP˶ʼnª∂„Å®ÂìÅË≥™‰øùË®º„Å´Èñ¢„Åô„ÇãÁü•Ë≠ò
  • ÂìÅË≥™„Ç∑„Çπ„É܄Ɇ„ÅÆÊîπÂñÑËÉΩÂäõ
  • „É™„Çπ„ÇØË©ï‰æ°„Å®ÂïèȰåËߣʱ∫ËÉΩÂäõ
  • Èñ¢‰øÇËÄÖ„Å®ÂçîÂÉç„Åó„Äʼn∫§Ê∏â„ɪ˙øÊ籠Çí˰å„ÅÜËÉΩÂäõ

Additional Requirements

  • ÂØæÈù¢Ê•≠Âãô„ÅåÂøÖȆà„Å߄ř„Åц¥Âêà„ÅØÂú®ÂÆÖÂã§ÂãôÂèØËÉΩ
  • Âπ¥„Ŵ˧áÊï∞Âõû„ÅÆÂõΩÂÜÖÂá∫ºµ„Åå˶ãËæº„Åæ„Çå„Çã
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