VBU治験薬GMP品質保証ヘッド応募後で応募 求人ID R0020442 掲載日 07/17/2020 Location:Hikari, Japan
1. Quality Assurance
- Executed batch records are reviewed and approved to ensure they meet current GMPs and internal procedures.
- Quality events (deviations, OOS/OOT and non-conformances) are investigated to identify root cause(s) and impacted materials and to establish effective CAPAs.
- Operations associated with production, validation activities, line clearance, cleaning and GMP environment receive appropriate oversight.
- Validation/qualification documents including VMP for process, methods, cleaning, equipment, computer and supporting systems are reviewed and approved.
- Final release/reject decision for raw materials, intermediates and finished products.
2. Quality Systems
- Change requests are assessed and correct implementation of the changes is ensured.
- Site documents such as Standards, SOPs/Instructions, MBRs and Product Master Files are developed, reviewed, approved and managed.
- GMP training programs are established and maintained and GMP training sessions are planned to ensure adequately training.
3. Quality Compliance
- Metrics for quality, operations, and product performance are trended.
- Customer complaints are investigated and appropriate CAPA are ensured.
- Regulatory inspections and customer audits are coordinated and organized.
- Site Quality Council Meetings are planned and hosted for management review.
4. Quality improvement projects are identified, aligned with global VBU quality and objectives, planned, and tracked to timely completion
5. Strategic projects, such as Quality Culture, are aligned with Global VBU quality expectations and timelines and receive appropriate priority
6. Foster and qualify talents in IMP GMP QA (VBU) with their career plan for sustainable growth of the organization.
7. Prepare IMP GMP QA (VBU) cost budget and oversee execution against plan/budget