Mô Tả Công Việc
_Develop analytical methods, formula for new products as assigned by Regional R&D-Technical Services Lead_Prepare ACTD dossiers_Prepare process validation procedures._Prepare process 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._Report occurrence of any deviation or technical problem within 24 hours of detection and recommend necessary measures to prevent occurrence of the same incident._Ensure compliance to Good Documentation Practices (GDP). Ensure that documents are accurate, up-to-date, and truthful at all times._Helping Regional 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.
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Yêu Cầu Công Việc
Professional Background _University graduate, major in Pharmacy preferred._Can speak and write in English._At least 5 years of experience working as R&D researcher/analyst in developing new products. _Familiar with equipment used in Production/Pilot. Competency Requirements_Self-management capability_Organizational capability_Strong cooperation/team work _Reliability (responsible, completes works in timely and consistent manner)_Sense of initiative and creativity_Quality of work: can maintain high standards even in pressing deadlines.
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Hình thức
Full-time
Mức lương
Thỏa thuận
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