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| 部署・役職名 | QA Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Position Purpose: Strongly promote the QA operation thereby ensuring that all processes and procedures, tasks, responsibilities, and projects are in compliance with all pharmaceutical laws, the company Quality Manual and Policies as well as Industry Best Practices. This role comprises special GxP requirements ＆ has to be executed in accordance with these. Ensure that all quality relevant processes are compliant, and that non－compliance is appropriately addressed via corrective ＆ preventive actions （CAPA） and/or escalation of issues Major Accountabilities: • Ensure implementation of applicable Quality Standards ＆ governance processes through the implementation of the company Quality Manual and Policies. Ensure that regulatory controls are in place in relevant process steps. • Ensures adherence to GxP, any further legal and company internal regulations for manufacturing, control and distribution operations and to HSE guidelines and requirements － Ensure implementation of defined Key Quality Indicators in the area of responsibility to monitor on an on－going basis that relevant processes are in control and compliant. • Ensure adequate regulatory inspection preparation, management and follow－up in the area of responsibility. Ensure communication with local Health Authorities is adequately shared within the organization and commitments tracked and closed on time. • Ensure implementation of adequate training within the area of responsibility for all GXP activities by defining, planning and supporting training activities. • Ensure that processes are in place to communicate country specific requirements to the Region and headquarter organizations for all GxP areas and assess their implications for the compliance of existing processes and systems. Initiate remediation activities, as necessary, to ensure ongoing compliance. • Ensures adequate processing of complaints. Establishes an efficient recall organization as well as ensure development of talent within the local Quality unit. |
| 応募資格 |
【必須（MUST）】 • Strong leadership• Management and practical work • Project Management • Collaborating across functional boundaries • Extensive and detailed knowledge of regulations and guidelines • Inspection Readiness • Quality decision making • Quality Management, Quality Assurance • Business Mindset • Operational Excellence • Stakeholder Engagement • Project Excellence • Interpersonal Savvy • Being resilient 【歓迎（WANT）】 • Equal or more than 5 year’s experience of quality assurance or quality control or equivalent role in pharmaceutical industries. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2024/02/28 |
| 求人番号 | 3324335 |
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- 会社規模101-500人
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です