Pharma R&D Specialist (Work Location: VSIP 2 - Binh Duong)

Mô tả Công việc

• Develop analytical methods, formula for new products as assigned by Regional R&D-Technical Services Lead
• Prepare ACTD dossiers
• Prepare process validation procedures.
• Prepare process 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.
• 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 Good Documentation Practices (GDP). Ensure that documents are accurate, up-to-date, and truthful at all times.
• Helping Regional 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

Professional Background 

• University graduate, major in Pharmacy preferred.
• Can speak and write in English.
• At least 5 years of experience working as R&D researcher/analyst in developing new products. Familiar with equipment used in Production/Pilot. 

Competency Requirements

• 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.