本ウェブサイトでは、ユーザーにウェブサイト上のサービスを最適な状態でお届けするためCookieを使用しています。ブラウザの設定(Cookieの無効化等)をそのまま変更せずに閲覧される場合は、弊社ウェブサイト上の全ページでCookieを受信することに同意したものとみなします。詳細は、弊社プライバシーポリシーをご覧ください。
本ウェブサイトでは、ユーザーにウェブサイト上のサービスを最適な状態でお届けするためCookieを使用しています。ブラウザの設定(Cookieの無効化等)をそのまま変更せずに閲覧される場合は、弊社ウェブサイト上の全ページでCookieを受信することに同意したものとみなします。詳細は、弊社プライバシーポリシーをご覧ください。
採用企業 | 武田薬品工業 |
勤務地 | 山口県 |
雇用形態 | 正社員 |
給与 | 850万円 ~ 1400万円 |
OBJECTIVES/PURPOSE
Provide leadership of Quality Assurance functions. Develops and deploys mid and longterm plan with KPIs and operational excellence, training/education, talent review and personnel development.
Managing aspects of Quality Assurance of API products, at the site, ensuring that quality systems, processes and related functions are in place and meet current Good Manufacturing Practices (cGMP), Takeda and other regulatory quality standards and requirements.
Ensure GMP compliant release of product manufactured and released on site, resp. the Mar-keting Authorizaton.
Review and approve site deviation investigations and assess product impact.
Responsible for excecution and review of Change Control and Validation.
Drive GMP on the shopfloor adherence in manufacturing area.
Achievement of defined plan with KPIs in order to drive the Hikari plant to reach operational and compliance excellence.
ACCOUNTABILITIES
Manages the API Quality Assurance organization making sure the site goals are cascaded into the department.
Support Product Shipping / Release Process and Product Disposition according to Hikari site Shipping and Release target dates
Review and approve plant deviation investigations and product impact assessments
Excecute and review Change Control and Validation
Guarantee that systems under Quality Assurance are managed according to Quality Systems global and local procedures and metrics.
Manage Quality on the floor activities in order to guarantee GMP Compliance and Continuous Improvement in Manufacturing areas
Manage the bioburden control program for process intermediates, critical/support systems and cleanrooms and perform investigations in case of deviations or negative trends.
Support manufacturing department during day by day activities and act as primary Quality contact for issues containment and resolution
Support Quality Control, Warehouses, Engineering and other supporting functions during day by day activities and act as primary Quality contact for issues containment and resolution
Responsible for the coaching, training, and development of the team and talent.
Ensures adherence to EHS program.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
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), SAP and Electronic Batch Management (EBM) systems 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, egender 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 “Qualtiy Culture”, "AGILE 4.0" "Digital" to drive continuous improvements.
Complexity
Key stakeholders include but not limited to: Quality Control, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.
職務経験 | 3年以上 |
キャリアレベル | 中途経験者レベル |
英語レベル | 基礎会話レベル |
日本語レベル | ネイティブ |
最終学歴 | 高等学校卒 |
現在のビザ | 日本での就労許可が必要です |
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline.
At least 5 years of management experience in the following areas in the pharmaceutical in-dustry: Quality assurance, Quality Control; understanding of the requirements for manufactur-ing, plant utilities, computer systems and project management.
In depth knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
Well-knowledge related to Manufacturing, Finance, EHS and HR (incl. Labor law)
Strong leadership skills (i.e. Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.)
Business level of English skill is necessary (both verbal and written)
Preferred
License for pharmacist
MBA
Experience of overseas assignment.
Preferred to have experience in managing team with applicable EHS perspectives such as waste, waste water, exhaust gas, noise, GHG reduction, health, and safety. (5 years for department head and 3 years for Group Managers)
Preferred to have experience in ISO 14001/45001 management system to carry out continuous improvement of site.
ADDITIONAL INFORMATION
Some travels will be required.
This job description is not designed to be a complete list of all duties and responsibilities required of the position.
雇用形態 | 正社員 |
給与 | 850万円 ~ 1400万円 |
勤務時間 | 8:00~16:45 |
休日・休暇 | 土曜、日曜、祝日、メーデー、年末年始など(年間123日程度) |
業種 | 医薬品 |
会社の種類 | 大手企業 (300名を超える従業員数) - 外資系企業 |