招聘人数：1 人
性别要求：不限性别
KEY ACCOUNTIBILITIES: Be the owner of one or more elements of the Pharma quality system, maintaining and working with document owner to improve the element(s). Work on electronic or paper base quality document system to provide daily document support and communicate with function department and ensure compliance with regulation. Specific responsibilities include but are not limited to the following: Responsible for daily inspection to ensure the effective execution of operation procedures and batch recordscommunication between area QA and function departments, report problems in timeParticipate in manufacturing related deviation, change, CAPA and OOSCooperate with self - inspection, customer and regulatory audit Participate tech transfer process and review protocols and reports Review and double check all original materials before submit to official
REQUIREMENTS: Minimum Bachelor degree in biology, biotechnology, or relevant disciplineMinimum 3 years quality experience, preferable in vaccine Lab or commercial product experience Understanding of cGMP/GLPs and ICH in the pharmaceutical industry well Good communication skills, particularly cross-function communication Good balance between having team spirit and working independently Familiar with questions and challenges in audits and regulatory inspections Demonstrated passion for document system field
ADDITIONAL POSITION SPECIFIC DUTIES/INFO (Not Covered in Generic Description of Job): Certifications with regulatory agencies (FDA、EU、WHO, etc.) preferred Certifications with quality system preferred Network with global QA team for good practice sharing and learning
求职提醒：求职过程请勿缴纳费用，谨防诈骗！若信息不实请举报。
