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:
- Right validation on first time and on time.
- High quality products
- Cost competitiveness
DUTIES and RESPONSIBILITIES
- 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.