United International Pharma

• Develop formula for new products as assigned by R&D Head.
• 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.
• Support the plant operational excellence program.
• Other duties as may be assigned.

Professional Background

• University or College graduate, major in Pharmacy or Chemistry.
• Can speak and write in English
• At least 2 years working in pharmaceutical companies as R&D or QA role, experience & knowledgein validation process/ reports.

Competency Requirements

• Self-management capability
• Organizational capability
• Strong cooperation/team work
• Reliability (responsible, completes works in timely and consistent manner)

- Chế độ bảo hiểm
- Xe đưa đón
- Chăm sóc sức khỏe
- Đào tạo
- Tăng lương
- Nghỉ phép năm