Specialist, Pharma QA Operational Governance & Strategy

必須

• １ Science Graduate or equivalent professional qualification and/or proven expertise
• ２ Experience of working at Quality Assurance Department of GMP pharmaceutical manufacturing site
• ３ Knowledge of Quality Assurance area, related general systems (Veeva, Trackwise, and LMS)
• ４ Strategical and logical thinking
• ５ Knowledge of GMP and other regulations as required with a broad knowledge of quality principles
• ６ Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the internal Astellas and external stakeholders.
• ７ Ability to develop and maintain effective relationships with internal and external stakeholders including Global Astellas entities.
• ８ Makes communications for the department in their area of quality expertise.
• ９ Ability to coordinate activities across multiple global stakeholders or sites, and to provide practical quality input based on GMP and operational understanding. Business proficient in English.

歓迎

• Science, industrial chemistry, biological chemistry or pharmaceutical degree preferred.

使用ツール

募集の背景 / Purpose & Scope

• This position collaborates with the commercial manufacturing site QA in Pharma QA / Bio Pharma QA to focus on document standardization activities and support/manage various activities for operational excellence.
• Responsible for development, implementation and management of standardized quality processes and governing the site operations so that the Astellas in-house plants within Pharma operate with a single, consistent and sophisticated GMP standard.
• Supports efficient operational management aligned to the circumstances of each site within Pharma QA, while coordinating with relevant stakeholders where broader alignment or quality input is required.

Responsibilities

• １ Collaborate with the manufacturing site's QA team to promote the standardization of procedural documents.
• ２ Lead or coordinate initiatives to ensure that plant-wide standard operating procedures (SOPs) are consistently applied and maintained.
• ３ Oversee the registration and maintenance of plant-wide SOPs in the Vault Quality system, ensuring compliance with regulatory and internal standards.
• ４ Conduct periodic reviews and updates of plant-wide SOPs to ensure they remain current and effective.
• ５ Implement activities to raise awareness of standardization projects among relevant stakeholders, ensuring that team members and related functions are informed and engaged.
• ６ Identify opportunities for improvement within manufacturing site QA processes and provide actionable proposals and support for enhancements.
• ７ Participate in cross-functional teams as needed, collaborating with other departments to achieve common goals and improve overall quality assurance practices.
• ８ Support manufacturing site and team for authority and/or internal self-inspection, and related CAPA activities.
• ９ Manage with team Head to ensure various activities for Phama QA operational excellence.

Accountabilities

• １ Ensure that procedural documents are standardized and compliant with industry regulations and internal requirements.
• ２ Maintain accurate records of SOP registrations and updates in the Vault Quality system.
• ３ Foster a culture of continuous improvement within the QA team and across relevant manufacturing site interfaces.
• ４ Act as a liaison between the QA team and other departments to facilitate effective communication and collaboration.
• ５ Report on the progress of standardization initiatives and process improvements to management, including relevant risks, issues and proposed actions where appropriate.

変更の範囲

• 会社内での全ての業務

就業環境に関する要件 / Specific Physical or Environmental Requirements

• This position is based in Japan, working closely with commercial manufacturing site QA, and will be offered a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home.