About this role
About Human Pharmaceutical Business With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Job Responsibilities In order to ensure Released product quality in accordance with BI SOP/cGMP/Registered Specification, perform manage complaints\ recalls\counterfeits \deviation management\ CAPA management\ Onsite GMP monitor \release activities under corporate management guideline and cGMP regulation. Update SOP related to Product quality function according to business needs and regular review to ensure comply with GMP and BI global requirement. As a Coordinator of project activities related to quality, ensure these activities in accordance with SOP/cGMP/Registered Specification.
Ensure the SOP execution comply with company’s and GMP regulation trough onsite inspection check. To evaluate batch records and to ensure that the batch records are reviewed before product release delegated by QP; And then release product in SAP system. As QP delegate, responsible for status change of finished goods and material (after QC usage decision) in SAP.
Assist to manage recall system, coordinate the recall execution, supervise the disposal of recalled goods, execute recall simulation and deliver related report. Update SOP related to quality complaint, product recall, ACF,. Assist to manage ACF process, cooperate China Anticounterfeiting Working Group to ACF investigation, deliver relevant report to Management in time.
As LPCO deputy, manage quality complaint system, including collect relevant complaint information, complaint sample management, investigate root cause, review complaint report, deliver conclusion and report archive, CAPA plan review, CAPA follow up, Meanwhile, provide training to plant. Ensure data integrity and accuracy in Go track system, includes timely input and output, and deliver monthly report. Organize to ensure Product Quality Review for product.
As local MSO for related quality systems or local key user for related system, responsible for Gap analysis, related Doc. update and training, routine execution and conduct continuous improvement. As SME in change project to ensure the project compliance with GMP regulation. Provide timely QA support for deviations root cause investigation, CAPA plan setting and follow up，PQR , Local new product launch .
Requirements: Bachelor or above, Pharmacy or relevant major Experience in similar role, minimum of 3 years' MNC experience of QA Excellent knowledge of GMP Good specific knowledge relevant to the area/field Excellent English language skills, both verbal and written Good organization and planning skills; good time management for emergent issue and priorities, and good at communication and team work spirit. Customer service focus and understanding of clients’ needs Confidence, professionalism, and efficiency in managing responsibilities Adaptability to change, willingness to share and learn Good analytical and scientific thinking and problem solving skills Excellent communication, negotiation and persuasion skills