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

This position reports to R&D Head.
JOB SUMMARY
Helping R&D team ensure a smooth flow in frontline operations to support the following goals:

High quality products
Right validation on first time and on time.
Cost competitiveness

DUTIES and RESPONSIBILITIES

Comply with change control requirements and ensure that no change is implemented without an approved change control document if applicable.
Develop formula for new products as assigned by R&D Head.
Prepare ACTD dossiers.
Prepare process, equipment, cleaning and computer validation reports.
Other duties as may be assigned.
Ensure compliance to Good Documentation Practices (GDP). Ensure that documents are accurate, up- to- date, and truthful at all times.
Prepare process, equipment, cleaning and computer validation procedures.
Support the plant operational excellence program.
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.
Monitor and review stability test results in accordance with the validation study.
Report occurrence of any deviation or technical problem within 24 hours of detection and recommend necessary measures to prevent occurrence of the same incident.
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.
Maintain records of relevant data and information gathered and other documents required by GMP, and regulatory agencies.

Professional Background

Experience: at least 2 years of seniority working as Researcher or R&D analyst.
Good communication in English
University graduate.
Pharmacist preferably, other relevant courses acceptable.

Competency Requirements

Strong cooperation/team work
Sense of initiative and creativity
Self- management capability
Reliability (responsible, completes works in timely and consistent manner)
Organizational capability
Quality of work: can maintain high standards even in pressing deadlines, does work right first time.

Laptop, Chế độ bảo hiểm, Du Lịch, Phụ cấp, Xe đưa đón, Đồng phục, Chăm sóc sức khỏe, Đào tạo, Tăng lương, Công tác phí, Nghỉ phép năm

Cập nhật gần nhất lúc: 2024-06-06 15:40:05