エージェント取り扱い求人

Vaccine Environmental Monitoring Staff/ワクチン環境モニタリング担当者(正社員/契約社員)

募集中
  • 勤務地
    山口県
  • 職種
    品質管理担当
  • 業種
    医薬品メーカー(先発医薬品)

募集要項

業務内容 職務内容

SOPに従いGMP製造エリアでの生菌サンプリング、微粒子サンプリングを含むグレードA~Dクリーンルームの環境モニタリング業務を実行する

水、蒸気などのクリーンユーティリティーの定常的サンプリング業務を実行する

SOP改訂業務、プロトコル作成または修正時に支援をする

査察や監査の際にSMEとして環境モニタリング業務の内容を説明する

環境モニタリング計画に従って環境モニタリングを実行する

環境モニタリングトレンド解析をおこない、

逸脱等に対する根本原因の調査を行い、CAPA計画を含む調査報告書を作成する

質問や提案を推奨する「Speak Up」を実践する

環境モニタリング業務や製造エリアの環境に関する改善提案を行う

環境モニタリングに関するProjectへ参画する。

コンプライアンス違反を報告する。
雇用形態 正社員/正社員
応募資格 <実務経験> 

医薬品の製造あるいは品質管理業務に関する職務経験

医療機器の製造・品質管理業務(微生物試験あるいは環境モニタリング)に関する職務経験

シフト勤務に対応できる

<学歴>

高卒以上

<スキル・資格> 

正確にデータ入力や資料作成を行う能力(Word/Excel等のPCスキル)

個人およびチーム環境でも業務を遂行できる能力

マスクを含む無菌衣を着用し、業務を遂行できる

<語学力>

英語力:読み書き可能

望ましい実務経験・スキル

無菌的環境での環境モニタリング業務経験

微生物学的試験

環境モニタリング業務

逸脱調査と報告書作成

トレンド解析

求める人物像 

協調性がある

人を思いやることができる

責任感がある

論理的思考ができる

批判的ではない

適切なコミュニケーションができる

偏った見方をしない

仕事のやりがい

自分たちの業務を通して、大切な患者様の健康のために確かな品質の医薬品を届けることができる。

高品質な医薬品を安定的に供給することによる社会への貢献

高い効能を持った高品質の医薬品を安定して供給するために努力する会社の一員として仕事ができること

世界水準での業務を行うことができる

本職務で身につくスキル・経験

世界標準の医薬品GMP要求事項の理解と実践

無菌医薬品の製造環境に関する要求事項と業務

汚染防止の概念

グローバルサイトの専門家との交流
英語力 読み書きレベル
年収 300万 〜 万円
給与詳細 300万円-
勤務地 山口県
備考 ”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us.
Takeda isa global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, whichhas been passed down since the company’s founding. Takeda-ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

企業情報

匿名

関連する求人

エージェント取り扱い求人
Cell Therapy Quality Assurance Manager or Specialist, Osaka Site / セルセラピー大阪品質 品質保証担当者(課長代理または一般社員)

【職務内容】 下記の主な業務を担当していただきます。 ・現場作業の監視・監督 ・逸脱調査 ・製造記録や試験記録などの照査 ・バリデーション ・変更管理 ・査察準備及び対応業務

  • 500万〜1300万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Head of Quality Control (Senior Director)

OBJECTIVES/PURPOSE Deputy Site Quality Head. Provide leadership of Quality Control functions. Develop and drive mid and longterm strategy and operational excellence, training/education, talent review and personnel development Accountable for and manage all aspects of Quality Control at the facility, ensuring that quality systems, laboratory compliance and related functions are in place and meet current Good Manufacturing Practices (cGMP), Takeda and other regulatory quality standards and requirements. Direct and ensure that laboratory operations are effective and carried out on schedule. Direct and ensure GMP compliant laboratory operations on site. Managing application of strategic goals Achievement of defined goals and targets in order to drive the Hikari plant to reach operational and compliance excellence ACCOUNTABILITIES Support Site Quality Head as deputy. Establish strategic goals for the Quality Control organization in alignment with the global and site strategy, and drive actions as needed to ensure timely delivery of goals. Lead and manage consistency in laboratory operations and data review process among Quality Control. Drive and lead new ways to improve and streamline current business and system processes. Identifies, manages, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements. Responsible for the coaching, training, and development of the Quality Control team. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge and experience in the field of analytical development and Quality Control function activities. Knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines. Knowledge in API, solid dosage forms, parenteral technology, biologics or combination products. Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations. Excellent verbal and written communication skills in both Japanese and English. Adaptive communication and presentation skills to effectively reach different levels, including senior management. Skilled in Microsoft Office applications (Excel, Powerpoint, Word) Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), and SAP preferred. Leadership Strong leadership skills and demonstrated success in managing a team. Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team. Adopt and exemplify the Takeda leadership behaviors throughout the GQ organization and Hikari Plant. Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals. Decision-making and Autonomy Must be able to deal with ambiguity, and make decisions under stressful conditions. Great sense of urgency. Interaction Interacts with the Site Quality Head and all site functions (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.) DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge and experience in the field of analytical development and Quality Control function activities. Knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines. Knowledge in API, solid dosage forms, parenteral technology, biologics or combination products. Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations. Excellent verbal and written communication skills in both Japanese and English. Adaptive communication and presentation skills to effectively reach different levels, including senior management. Skilled in Microsoft Office applications (Excel, Powerpoint, Word) Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), and SAP preferred. Leadership Strong leadership skills and demonstrated success in managing a team. Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team. Adopt and exemplify the Takeda leadership behaviors throughout the GQ organization and Hikari Plant. Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals. Decision-making and Autonomy Must be able to deal with ambiguity, and make decisions under stressful conditions. Great sense of urgency. Interaction Interacts with the Site Quality Head and all site functions (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.) Interacts with global Quality functions and Regulatory Affairs, as well as local and global regulators. Interacts frequently with subordinates, functional peers, and the Senior Leadership Team. Innovation Strong knowledge of Quality Risk Management principles. Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products. Identify and implement strategic opportunities to drive cost reductions/process improvements in site-business. Lead and engage employees by initiatives of “Qualitiy Culture”, "AGILE 4.0" "Digital" to drive continuous improvements. Complexity Key stakeholders include but not limited to: Quality Assusrance, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.

  • 1300万〜1700万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Head, Commercial Vaccines Quality, Japan

ACCOUNTABILITIES The role is accountable for the overall quality strategy and quality management system of commer-cial vaccines operations and supplies in Japan. The Head of commercial Vaccines Quality is respon-sible to design, deploy, monitor and improve the quality management system and for compliance to current Good Manufacturing/Distribution & Laboratory Practices and compliance to Takeda global standards and overall Hikari Site Standards. The Head of commercial Vaccines Quality partners with the GMS site quality head and aligns on site quality strategy, a harmonized cross-plant quality philosophy & joint quality initiatives and main-tains good day to day collaboration between the 2 site quality organizations. Ensures that new/revised quality system requirements are deployed to the site timely. Ensures execution leads for Quality-owned business processes are established who work with the business process owner to continually execute compliantly & improve on site processes. Responsible for Japan vaccine quality performance, continuous improvement and Q-metrics (KPI) monitoring to ensure global and site targets are achieved, met and countermeasures are in place when applicable. Responsible for Quality Control testing and sampling for commercial vaccines (Bulk Drug Substance and Drug Product (BDS, DP)) and partners with other Takeda laboratories or external laboratories for testing that is performed on behalf of vaccines quality (eg. Microbiology, Environmental Moni-toring, Raw Materials) Responsible to establish the appropriate quality oversight for outsourced activities such as testing as well as quality assurance review of site validation activities. Development and refinement of groups’ specific quality systems and procedures. Committed to continuous improvement and responsible to proactively mitigate current and future risks to maintain an effective operation to support business needs. Living Takeda’s values (Takeda-isms) and fostering a Quality Culture culture of trust and and speak up culture within the team. Assuring appropriate GMP and QA systems training of Quality personnel and continuously develop team´s capabilities and expertise. Accountable for quality oversight of site quality management systems (CAPAs, Change Controls, Deviations, Formal Risk Management, facility/equipment/process qualification) Responsible for site specific QMR management and gathering of APQR data. Align with GMSGQ team and provide QA support for electronic system integration: LIMS, Trackwise, SAP etc. Responsible for vaccine batch disposition decisions taking into account all relevant information and escalation processes. Oversight of execution of product disposition (drug substance). Responsible to ensure sufficient and adequate quality oversight of vaccines manufacturing and distribution processes. Preparing for/ supporting/ leading internal and health authority regulatory inspections and third-party audits, including communicating with and providing information to regulatory submissions or bodies. Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity/training, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group. Responsible for management of cross-plant quality issues and timely escalation of vaccines related issues within the global Takeda VBU organization. Responsible for budget planning and managing expenses and for timely hiring, training and devel-opment of qualified staff to ensure effective execution of roles and responsibilities, GMP compli-ance, and attainment of operational and development goals.

  • 1300万〜1700万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Manager or Specialist, Quality Assurance, Narita Site / 成田工場 品質保証担当(課長代理または一般社員)

医薬品の品質保証業務における以下業務のうち、複数を担って頂く予定です。 ショップフロアQA(現場作業を直接監視・監督) バッチレコードを含む書類の照査 逸脱調査 業務範囲は、武田薬品成田工場の生産部門及び試験部門であり、対象製品は無菌注射剤(血漿分画製剤)です。武田薬品とのグローバル化対応も含みます。

  • 500万〜1300万
  • 千葉県
  • 医薬品メーカー(先発医薬品)

募集中