QA Stability Analyst (Work location: Factory in VSIP 2 - Binh Duong)
Lương thỏa thuận
Hóa học, Dược phẩm, Quản lý chất lượng (QA/QC)
Mô Tả Công Việc
QA Stability Analyst monitors stability study according to defined program to ensure a smooth flow in frontline operations to support the following goals:
- On-time delivery of finished goods
- High quality products
- Cost competitiveness
- Prepare stability protocol for in-process bulk and finished goods per product.
- Provide monthly schedule for stability testing. Co-ordinate with QC Laboratory to ensure that required testing done properly.
- Ensure that samples are withdrawn and tested as per schedule.
- Prepare Accelerated/Long-term Stability Report per stability cycle or per regulatory request.
- Manage samples under stability study. Ensure correctness of labeling & storage condition.
- Ensure of adequate stability chamber condition complies with regulatory requirement.
- Report occurrence of any deviation or technical problem within 24 hours of detection and recommend necessary measures to prevent occurrence of the same incident.
- Ensure compliance to safety rules and regulations and actively participate in activities on safety and environmental aspects of the company.
- Comply with change control requirements and ensure that no change is implemented without an approved change control document if applicable.
- Ensure compliance to Good Documentation Practices (GDP). Ensure that documents are accurate, up-to-date, and truthful at all times.
- Participate in Operational Excellence (OE) programs in the QA Services Department.
- Perform economy of budget in Quality Assurance Services.
- Perform other duties and responsibility as may be assigned from time to time.
Yêu Cầu Công Việc
- University graduate in Pharmacist, Chemical Engineer, Chemist or other related sciences.
- Can speak and write in English
- At least 2 years working in pharmaceutical industry.
- Accountability & Responsibility
- Attention to details
- Continuous improvement
- Teamwork and collaboration
- Interpersonal skills
Kết nối với chúng tôi
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