Helping R&D team ensure a smooth flow in frontline operations to support the following goals:
On-time delivery of finished goods
High quality products
Cost competitiveness
DUTIES and RESPONSIBILITIES
Develop formula for new products as assigned.
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.
Other duties as may be assigned.
Job Requirement
Professional Background
University or College graduate, major in Pharmacy or Chemistry.
Can speak and write in English.
R&D experience in pharmaceutical companies, knowledge in validation process/ reports.
Competency Requirements
Self-management capability
Organizational capability
Strong cooperation/team work
Reliability (responsible, completes works in timely and consistent manner)
