面議(經常性薪資達4萬元或以上) 新竹縣新豐鄉 7年工作經驗 1天前更新
1. Leading and ensuring to meet specific timeline in compliance with quality
assurance management
(1) Documentation control (master batch record, specification & method).
(2) Batch record review and product disposition.
(3) Investigations, complaints, deviations, CAPAs, APRs.
(4) Production support.
(5) APRs, GMP training, and SOP review.
(6) Validation/qualification documentation review & approval.
(7) QA Operations – inspection, sampling, and review of incoming materials,
perform AQL inspections, support, and drive compliance throughout the site.
(8) Departmental budget development and compliance.
(9) Regulatory and customer inspections management.
(10) Trend Analysis and Risk Assessment
(11) Stability Sample Management
(12) Regulatory Submission Documents Support
(13) Quality management review – quality meeting and related KPIs.
2. Leading organizational change; developing and empowering staff; cultivating
relationships; putting staff in a position to succeed, meeting their personal
career goals while also achieving organizational goals.Driving engagement
and creating a climate where staff is motivated to do their best.
3. Ensure the QA successfully performs batch disposition activities to meet
specified timelines.
4. Ensuring the quality and compliant production and disposition of batches
and the quality and compliant operation of all systems throughout the
facility in accordance with schedule requirements.
5. Leading and ensuring the group is leading and participating in continuous
improvement projects throughout the group and the facility/operational
portions of the organization.
6. Execution of Other Tasks Assigned by Management.
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