R&D Specialist (Work location: VSIP 2_Binh Duong)
Lương thỏa thuận
Mô Tả Công Việc
- Develop formula for new products as assigned by Technical Services Team Leader
- 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 TS 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 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.
- Support the plant operational excellence program.
- Other duties as may be assigned.
Yêu Cầu Công Việc
- Master/Bachelor degree of Pharmacist.
- Experience: at least 2 years of seniority working as researcher or technical services analyst.
- Can speak and write in English fluently
- Self-management capability
- Organizational capability
- Strong cooperation/team work
- Reliability (responsible, completes works in timely and consistent manner)
- Sense of initiative and creativity
- Quality of work: can maintain high standards even in pressing deadlines, does work right first time.