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

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.
Helping R&D team in timely preparing and implementing regulatory-compliant procedures for corrections and corrective actions of technical issues.
Report occurrence of any deviation or technical problem within 24 hours of detection and recommend necessary measures to prevent occurrence of the same incident.
Other duties as may be assigned.
Prepare ACTD dossiers.
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.
Conduct field investigation to determine true root causes of issues, if applicable.
Prepare process, equipment, cleaning and computer validation procedures.
Support the plant operational excellence program.
Ensure compliance to Good Documentation Practices (GDP). Ensure that documents are accurate, up-to-date, and truthful at all times.
Comply with change control requirements and ensure that no change is implemented without an approved change control document if applicable.
Prepare process, equipment, cleaning and computer validation reports.

Professional Background

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

Competency Requirements

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

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

Cập nhật gần nhất lúc: 2022-06-17 11:22:04