Prepare equipment, cleaning and computer system validation procedures.
Prepare equipment, cleaning and computer system validation reports.
Monitor and review stability test results in accordance with the validation study.
Prepare ACTD dossiers.
Support develop formula for new products, improve formula for existing products as assigned by Technical Services Head.
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.
Ensure compliance to Good Documentation Practices (GDP). Ensure that documents are accurate, up-to-date, and truthful at all times.
Helping Technical Services team in timely preparing and implementing regulatory-compliant procedures for corrections and corrective actions of technical issues.
Support the plant operational excellence program.
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.
At least 2 years working in pharmaceutical companies as R&D or QA role.
Experience & knowledge in Equipment validation, CSV - Computer System Validation process/ reports.
Competency Requirements
Self-management capability
Organizational capability
Strong cooperation/team work
Reliability (responsible, completes works in timely and consistent manner)
