3 - 5 Năm
- Cấp bậc
- Hết hạn nộp
- Chế độ bảo hiểm
- Xe đưa đón
- Chăm sóc sức khỏe
- Đào tạo
- Tăng lương
- Nghỉ phép năm
Mô tả Công việc
Helping R&D team ensure a smooth flow in frontline operations to support the following goals:
- On-time delivery of finished goods
- High quality products
- Cost competitiveness
DUTIES and RESPONSIBILITIES
- Develop formula for new products as assigned.
- Prepare ACTD dossiers.
- Prepare process, equipment, cleaning and computer validation procedures.
- Prepare process, equipment, cleaning and computer validation reports.
- Monitor and review stability test results in accordance with the validation study.
- Maintain records of relevant data and information gathered and other documents required by GMP, and regulatory agencies.
- Consult, coordinate and provide adequate support to R&D team and Production to ensure smooth flow of daily frontline operations. Eliminate root causes related to R&D.
- Report occurrence of any deviation or technical problem within 24 hours of detection and recommend necessary measures to prevent occurrence of the same incident.
- 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.
- Helping R&D team in timely preparing and implementing regulatory-compliant procedures for corrections and corrective actions of technical issues.
- Conduct field investigation to determine true root causes of issues, if applicable.
- Other duties as may be assigned.
Yêu Cầu Công Việc
- University or College graduate, major in Pharmacy or Chemistry.
- Can speak and write in English.
- R&D experience in pharmaceutical companies, knowledge in validation process/ reports.
- Self-management capability
- Organizational capability
- Strong cooperation/team work
- Reliability (responsible, completes works in timely and consistent manner)
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