求人情報詳細
外資系製薬メーカー 理化学試験Leader
正社員
1000万円
| 仕事内容 | 品質保証本部にて理化学試験のLeader(責任者)をお願いします。 職務内容 <職務/Job Responsibilities> This position is responsible for the management of his/her team and has the following principal accountabilities as an area supervision/technical resource/technical Subject Matter Expert (SME). ・Manage the quality system of analysis for semi-finished products and final products. ・Build the quality system based on the Global Audit, Site Quality plan, and GQS/LQS requirements. ・Extend Japanese high quality level to the other sites by effective communication. ・Manage team staff and support to get the opportunities to increase the advanced skill and the GMP knowledge. ・Certify team members to perform each role. ・Review and approve QC testing/inspection results, deviations, changes, Analytical Investigation report for invalidated OOS/OOT per procedure. ・Review and approve QC technical documents as appropriate. Safety, Quality, Compliance&Service ・Always pay attention to and proactively participate the Health, Safety and Environment (HSE) related activities in order to achieve zero serious incident and fatality. ・Provide guidance and consultation to others for HSE improvement. ・Manage and control overall system of analytical test for semi-finished products and final products. ・Understand the GMP/QMS and the Pharmaceutical Affairs Law, and educate the subordinates to handle in an appropriate manner. ・Gain sufficient technical/transferable skill, provide solutions for technical problems and operational support to team members. ・Process&Operational Excellence ・Serve as QC Process Team Leader to ensure safety, quality, capacity and execution excellence. ・Communicate with global/local counterparts to solve problems and enhance Operational Excellence. ・Lead projects for compliance, efficiency, operational excellence and/or optimization. (e.g., lean, global/local projects, lab equipment recapitalization, new products launch preparation) ・Make sure all required activities are planned and executed, such as equipment periodic maintenance or stability program. ・Maintain the validated state of analytical method and equipment following method transfer and/or equipment qualification. ・Identify and implement process improvements to continually enhance the quality of the operations, workflow, and procedures. People, Organization&Others ・Communicate with team members periodically to work properly, and provide appropriate supports and opportunities for team members' development and career planning. (One-on-One / Performance Management /Development plan etc.) ・Develop staffs that have the technical/transferable skill and confirm the training records. ・Reexamine and adjust human resource/equipment capacity periodically to build more systematic and more highly qualified team. ・As QC Lead Team member, develop and implement strategic plan, manage and control team expense and resource. |
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| 経験・資格 |
※求人情報の応募要件全てに該当しなくても、企業様に対して内々に打診したり相談することが可能な場合もございます。一つでも当てはまる方は前向きにご検討下さい。
・科学分野または医療分野の学士号・製薬QCラボでのGMP/GQPおよび薬事法に基づく経験 ・化学および/または微生物学および/または生物学的試験、分析方法の移転、ラボ機器に関する知識/経験 ・グローバル環境での実務経験 <必須経験Mandatory requirements/スキル・資格Skill/Certification> ・Bachelor’s degree in a scientific area or health care field ・Experience in the pharmaceutical QC labs under GMP/GQP and Pharmaceutical Business Law or equivalent ・Knowledge/Experience of analytical testing (Chemical and/or Micro-biological and/or Biological testing), analytical method transfer, and lab equipment ・Work experience under global environment ・Strong oral and written communication skills in Japanese and English (Japanese: Native level, English: Business level (TOEIC>850, Versant score>52)) ・Strong self-management and organizational skills; able to manage multiple priorities and appropriately network across a wide variety of functional components and business partners ・Strong interpersonal and collaborative work style, including the ability to provide leadership and promote teamwork among individuals with diverse style ・Strong ability of people management, operation management, project management, problem solving, influence others and stakeholders without direct positional authority ※更なる詳細事項は、カウンセリング（面談）時にお伝えします。 |
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| 推奨年齢 | 30代 | ||||||||
| 想定年収 | 950 万円 ～ 1000 万円 | ||||||||
| 勤務地 | 兵庫県神戸市 | ||||||||
| 企業データ |
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| Recruiting No. | 02000692000983 | ||||||||
| ひとことコメント | 創業時から研究開発に注力。特化した分野で確かな地位を築く。学閥なし、プロパー優遇なし、職位による差別なし。人物をフェアに見る社風。 |
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