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| 部署・役職名 | 品質管理(工場QC):理化学試験のLeader/責任者 |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
<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. |
| 労働条件 |
【就業場所】 神戸市内の工場 従事すべき業務の変更の範囲:当社業務全般 就業場所の変更の範囲:将来のキャリアの一環として、兵庫・東京・神戸市内の工場・海外オフィスでの勤務をする場合もありうる ※社員のウェルビーイングと生産性の観点から、自宅最寄り駅から勤務地までの通勤距離が90㎞以内かつ公共交通機関の所要時間が90分以内の範囲を、通勤可能上限としています。 それよりも遠方にお住まいの場合は、通勤可能な範囲にご転居いただくことを原則としております(借上社宅の貸与あり)。車両通勤を認める場合においても、上記を適用します。 <処遇> 【給与】参考月額基本給763,200円以上 当社規定により優遇します 【諸手当】住宅手当、通勤交通費など 【昇給】有り 【賞与】個人業績結果及び会社業績結果に基づく業績変動賞与を支給する。 支給時期は、営業職は9月および翌年3月に支給、非営業職は翌年3月に支給。 【勤務時間】8:45~17:30 【時間外手当】なし 【清算制フレックス勤務】適応あり。フレキシブルタイム:5時~22時内で勤務。 (ただし、一斉休憩を除く)1日の必要最低労働時間:4時間(半日休暇時は2時間) 一斉休憩:12時~13時 【在宅勤務制度】有 【受動喫煙対策】あり 就業場所 全面禁煙 【休日休暇】完全週休2日制(土・日曜日)、祝日、年末年始・夏期 *年間休日125日、年次有給休暇、慶弔等 【保険】雇用・労災・健康・厚生年金保険 【福利厚生】住宅援助制度、借上社宅制度、グループ補償制度(医療費・歯科医療費補助制度等) 【定年制】有(60歳) 【継続雇用制度】有(65歳まで) 【有給休暇】 年途中で入社した社員に対する年次有給休暇は、入社月の区分に従い入社の翌月1日に付与される。入社日にかかわらず、その年の12月31日をもって、勤続年数が1年経過したものとみなし、翌年1月1日に翌年度の年次有給休暇が付与される 【試用期間】6か月間 試用期間中での賃金の違いはございません |
| 応募資格 |
【必須(MUST)】 <必須経験 Mandatory requirements/スキル・資格 Skill/Certification>・Bachelor’s degree in a scientific area or health care field ・Minimum of 5+ years of 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 ・5+ years 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 |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/10/24 |
| 求人番号 | 4340955 |
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