R&D Analyst (Work Location: Vsip 2 - Binh Duong)

Report to: R&D Senior Manager.
Working location: Binh Duong Factory. / Địa điểm làm việc: Nhà Máy Bình Dương - Số 16, Đường số 7, KCN Việt Nam - Singapore II, P. Hòa Phú, TP. TDM, Bình Dương.
JOB SUMMARY
Helping R&D team ensure a smooth flow in frontline operations to support the following goals:

High quality products
Cost competitiveness
On-time delivery of finished goods

DUTIES and RESPONSIBILITIES

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 reports.
Prepare process, equipment, cleaning and computer validation procedures.
Monitor and review stability test results in accordance with the validation study.
Helping R&D team in timely preparing and implementing regulatory-compliant procedures for corrections and corrective actions of technical issues.
Other duties as may be assigned.
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.
Prepare ACTD dossiers.
Conduct field investigation to determine true root causes of issues, if applicable.
Support the plant operational excellence program.
Maintain records of relevant data and information gathered and other documents required by GMP, and regulatory agencies.
Comply with change control requirements and ensure that no change is implemented without an approved change control document if applicable.

Professional Background

At least 1 yearworking in pharmaceutical companies as R&D or QA role, experience & knowledgein validation process/ reports.
Can speak and write in English.
University or College graduate, major in Pharmacy or Chemistry.

Competency Requirements

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

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

Cập nhật gần nhất lúc: 2022-06-19 22:32:03