エージェント取り扱い求人

Staff, Vaccine QA Quality Operations / ワクチン 品質保証(クオリティ・オペレーションズ)担当者 (契約社員)

募集中
  • 勤務地
    山口県
  • 職種
    その他製剤化/製造・生産関連職
  • 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

・製造および試験設備の導入に関連する文書レビュー

・技術移管関連の文書レビュー

・バリデーション関連の文書レビュー(バリデーションマスタープラン、プロセスバリデーションなど)

・GMP製造のための文書レビュー(マスターバッチレコード、試験法など)

・製造時の品質保証業務(現場監視、実施済のバッチレコードレビューなど)

・ワクチンの出荷に関連する業務 当局査察の対応

※ご経験やキャリア志向を勘案して、上記の中から担当業務を幾つか選択させていただきます。
雇用形態 契約社員
応募資格 <学歴>

理系大学卒業以上(化学、工学、生物学、農学など)

文系大学及び高校・高専卒業以上

<実務経験>

下記すべてを満たしている必要はありませんが、下記の項目の経験を重視します。

・製造業での業務経験(製造部門、技術部門、品質部門など)

・GMP業務経験(製造部門、技術部門、品質部門など)

・変更管理や逸脱処理(調査、是正、予防)の基本的な知識や経験

・GMP査察への対応経験(査察実施経験も可)

・科学的なデータに基づいた状況判断

・メールなど英語でのコミュニケーションを伴う業務経験

<スキル・資格>

下記すべてを満たしている必要はありませんが、下記の項目の経験を重視します。

・製造業、GQPあるいは医薬品GMPに関する基礎知識

・変更管理や逸脱処理(調査、是正、予防)の基本的な知識

・GMP査察への対応経験(査察実施経験も可)

・統計解析ソフト、BIソフトやRPAを用いた業務経験

<語学>

下記すべてを満たしている必要はありませんが、下記の項目の経験を重視します。

・ビギナーレベルの英語スキル(読み書き)

・英語のスピーキング、リスニングを伴う業務経験を歓迎します

・今後ビジネスレベルでの英語スキルを高める意欲のある方を歓迎します

求める人物像

・グローバル色が強い組織の一員として、国籍・人種・性別などのダイバーシティを受け入れて、多様なメンバーと働く意欲のある方を特に歓迎します。

・ワクチンQA/QOpsの品質保証業務は多岐にわたります。新しい業務や不慣れなことにも前向きに挑戦する意欲のある方を歓迎します。

・製品の安定供給に当たっては、多数のステークホルダーとの協働が重要です。他部署の従業員と協調して業務出来る方を歓迎します。

仕事のやりがい

業務を通じて、ワクチンを通じた日本における公衆衛生に大きく貢献できます。70年以上にわたるワクチン製造の歴史と、最新鋭のロボットを備えスピーディーかつ安全な製造プラントを学ぶ事が可能です。また、最先端を走るパートナーとのワクチンの開発について知る事もできます。加えて、グローバル組織の一員として、将来的にグローバルを舞台に活躍することも可能です。

本職務で身につくスキル・経験

・医薬品GMPにおける品質保証の知識

・英語を用いた業務スキル

・ワクチンを開発・改良するために必要な規制や業務に関する知識

・様々な部署と協働するためのスキル(交渉力、コミュニケーション)

その他

ワクチンQA/QOps は、新しい組織になります。新しいことに挑戦したい方、新しい仕組みを作りたい方にはやりがいのある組織です。また、グローバル組織の一員として経験を積むことで、将来的に海外のメンバーとかかわる業務に携わりたい方を歓迎します。

*製造時・トラブル対応時には、土日出勤が発生する可能性があります。
英語力 読み書きレベル
年収 500万 〜 800万円
給与詳細
月額(基本給):310,000円~
<昇給有無>有
<残業手当>有
<給与補足>
※年収は前職の経験を考慮の上、規定により決定します。
■昇給:原則年1回
■賞与:年2回
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.
global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of ism, whichhas been passed down since the company’s founding. 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
Manager or Specialist, Quality Assurance, /品質保証担当(課長代理または一般社員)

【職務内容】 工場において、医薬品の品質管理及び品質保証業務における以下業務を担うリードもしくは担当者です。 ・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 ・出荷判定  ・バリデーション ・変更管理 ・試験記録のレビュー など 業務範囲は、光工場の生産部門及び試験部門であり、対象製品は原薬/固形製剤、麻薬製剤などがありますので、適性と経験を考慮します。 【キャリアの展望】 この業務を経験されると、国内外の医薬品に関する品質保証業務全般の知識スキルを習得する事が出来ます。また、製薬品質保証室には、原薬、固形製剤、無菌製剤、ワクチンを担当するグループもあり、品質保証室内のローテーションにより幅広い剤型に対する品質保証エキスパートになれる機会が得られます。

  • 500万〜1300万
  • 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, Vaccine DP Development / ワクチン製剤技術研究 担当者または課長代理

職務内容 以下のワクチン注射製剤の製剤開発に関する業務に従事頂きます。 製剤設計(処方、剤形の設計) 製剤製造プロセス設計(治験段階~商用に応じた製剤製造法の開発) バリデーション、治験薬製造設備・機器の管理、治験薬製造・供給 商用スケールへのスケールアップ検討、商用部門への引き継ぎ 申請書類の作成、照会事項対応、査察対応など

  • 500万〜1300万
  • 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
Process Engineering Associate Director, Japan New Plasma Facility Project

OBJECTIVES/PURPOSE Own Process Equipment is “fit for purpose” for the manufacture of drug substance and drug products, meeting Regulatory, Quality, Capacity and EHS requirements Main objectives (key services) Technology selection Capacity Modeling and Site Master Planning Engineering and Equipment Design Safety engineering design and management “Factory Floor” Continuous Improvement/ Troubleshooting / System ownership Own strategic preparation of sites for the future by introducing new process technologies such as robotics and delivering agile process engineering solutions Provides leadership to all engineering disciplines during the development of the project requirements, scope, design (concept, basic, and detail), timeline, and budget# The incumbent is responsible for improving existing equipment to minimize production downtime and provide leadership to all process equipment related investigations Develop and implement strategies to ensure cost and time effective designs while ensuring innovation and adhering to user requirements while managing daily operational support ACCOUNTABILITIES Technology selection Drive Cross functional stakeholder management with our Partners in Manufacturing e.g. Sciences and/or Pharmaceutical Sciences. Sponsor the evaluation and selection of new, state-of-the-art technologies and process equipment and applicable process equipment vendors (e.g. Robotics Single Use Technology) Identify future industry trends and decide on strategies for process equipment/technologies Own business case development for CAPEX investments in process equipment incl. Total Cost of Ownership (TCO) calculations Manage Process Equipment Vendors and Architectural/Engineering firms in the delivery of CAPEX and OPEX projects in areas of responsibility Capacity Modeling and Site Master Planning Mentoring of Process Unit Operation Capacity models and identify capacity bottlenecks / constraints in GMP manufacturing processes / production process and in the utilities delivery systems Apply knowledge of heat transfer, mass transfer, fluid dynamics, reaction kinetics to solve common process engineering problems Engineering and Equipment Design Own Front-End Engineering and Design activities in feasibility study and conceptual design phases Sponsor Project Turnover Packages for Process Equipment are delivered to site and that critical engineering knowledge such as as-built drawings, operating and maintenance manuals, equipment and instrument data sheets, spare parts lists are maintained, remain accurate and up to date Gather requirements from Stakeholders - such as from Quality, Manufacturing, Reliability, Maintainability, Automation, and EHS – to decide on Process Basis of Designs, specifications and designs for Process Equipment, Process Control Systems, Process Instrumentation and Process Safety Systems and Devices Lead Scope of Work and RFx Packages for Process Equipment Vendors, Process Engineering Consultants, Architectural / Engineering services, Commissioning services and (Sub-) Contractors Sponsor commissioning activities such as Factory Acceptance and/or Site Acceptance Testing of process equipment With Partners in Engineering Validation mentor the Qualification and Validation activities for Process Equipment SME Design Reviews of Process Equipment with Stakeholders, including Quality, Manufacturing, Utilities Operations, Maintenance, Calibration, Reliability, Automation Safety engineering design and management Conduct Process Hazard Analysis (e.g. PHA-Hazop) of hazardous manufacturing / production processes and incorporate improvements into the design of process equipment, process control, and process safety systems Perform Design Reviews of all process equipment with relation to EHS and lead for the relevant changes Own Investigations for process equipment and implement Corrective and Preventive Actions (CAPA) “Factory Floor” Continuous Improvement/ Troubleshooting / System ownership Provide leadership the Manufacturing and Maintenance departments with troubleshooting activities of Process Equipment on the factory floor Owner continuous improvement activities for Process Equipment applying continuous improvement tools such as DMAIC, FMEA, RCA, identify improvements, design and implement improvements and sponsor 3rd level troubleshooting in collaboration with “Manufacturing” &” Manufacturing sciences” Mentor Management of Change for Process Equipment in area of responsibility Responsible for internal and regulatory Audits and Inspections Engage in the Process Engineering Community of Practice (CoP) through sharing of best practices and lessons learned DIMENSIONS AND ASPECTS Technical Expertise: Lead and mentor system/equipment specifications Determine basic causes, and develop and then follow up on recommendations for corrective actions Enable capabilities to perform troubleshooting on system/equipment Lead customer service problems and recommend design improvements Leadership: Displays and drives culture of -ism, PTRB, safety, and quality into the organization Be on the floor to study and train and recommend techniques to enable the team to improve existing equipment to minimize production downtime. Good interpersonal skills and be able to work effectively and efficiently in a team environment as leader, mentor, trusted advisor. Demonstrates strong communication skills to effectively communicate with all levels of professionals, both internal (local & global) and external Coach, motivate, develop, recognize and mentor the engineering staff, including senior level engineers and managers. Being a mentor developing future leaders Decision-making and Autonomy: Decision making on organizational changes to build the required capacity/capabilities Autonomy in decision making to the level of required alignment Decision making of short/mid & long-term impacts Interaction: CAPEX Project Teams, Manufacturing Sciences, Quality, Manufacturing / Production, Utilities/Facilities Operations, Plant/Facilities/Utilities Engineering, Reliability Engineering, Maintenance, Calibration, Automation, EHS, Procurement / Purchasing, Equipment Vendors, Architectural / Engineering Services Companies, (Sub-) Contractors, Consultants Innovation: Generate innovative solutions to highly complex problems Demonstrated problem solving skills to support resolution of Engineering, Manufacturing and/or Quality-related issues Complexity: Assess, analyze, advise, propose and direct improvements that will deliver greater productivity, capacity, reliability and compliance for the Process Engineering Department Ensure compliance to all regulatory GMP, Safety and Environmental requirements Shall interface with regulatory agency representative (e.g. FDA/EMA) as the site Process Engineering SME during internal and external audits and shall be able to defend current practices to such agencies Strong skills to work in matrix organization with excellent interpersonal, communication, influencing, and negotiation skills required

  • 1300万〜1700万
  • 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
CAPEX Project Director, Japan New Plasma Facility Project

OBJECTIVES/PURPOSE Coordinating the engineering activities of about 1000 Oku Yen investment at the Osaka Site, Japan, to implement an end to end manufacturing facility for Plasma Derived Therapy products including Drug Substance (DS), Drug Products (DP), Inspection and Packaging (I&P) and a Cold warehouse. ACCOUNTABILITIES Develop and manage project budgets, ensuring that all expenditures are in accordance with approved budgets. Manage project risks, ensuring that risks are identified, assessed, and mitigated in a timely manner Provide regular project status updates to senior management and other stakeholders. Ensure compliance with all applicable regulations, guidelines, and policies. Provide regular management up-dates and act as an enabler for individual project teams. Use project management methodologies and skills to manage the capital project across organizational boundaries and is responsible for its successful delivery. Ensures the project is conducted at the highest quality, within time and budget, and that the risk level and stakeholder expectations are managed. Ensures adherence to the GMS GOP - Planning and Execution of Capital Investment Projects Coordinates and supervises project execution related activities, from initiation to close out and successful hand-over. Leads a cross functional team of internal and external specialists. Responsible for meeting project scope requirements, schedule requirements, and costs. Interfaces with major projects/initiatives at the specific plant. Transfers best practices across functions and business units as well as other sites. Ensures compatibility and consistency with the existing organization and industry standards (PMM, cGMP, GEP, etc.) Coordinates with all stakeholders, facilitates problem solving sessions and or other planning sessions, and makes adjustments to the project in alignment with the overall business strategy. Responsible for the adequate utilization of all quality systems as defined by Procedures within the project organization. Ensures appropriate safety measures are taken to prevent injuries and minimizes safety risks. Ensures readiness for inspections together with quality organizations. Ensures compliance with rules and regulations of procurement and accounting.

  • 1300万〜1700万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中