Job Information
Boehringer Ingelheim QA Manager II in Shanghai, China
About Biopharmaceutical Contract Manufacturing
Boehringer Ingelheim aims to become China's first international provider of biopharmaceutical contract manufacturing solutions with all-round services to its clients in China and all over the world. As the leader in biopharma CMO manufacturing, Boehringer Ingelheim introduces innovative business models into China to further promote development of China's biopharma industry, boosting global competitiveness of Chinese biopharma companies, and facilitating clinical research and market launch of China's innovative medicines in a bid to accelerate growth of China's bio-technology industry. The Company's state-of-the-art production platform, management system and global biopharma network will help bio-medicines made by Chinese companies to enter the global markets.
Responsibilities
-End to end GMP Duties & Oversight on GMP activities of assigned GMP areas（ e.g: DS area in Ha Lei Road and Li Shi Zhen Road site，QC testing related to DS).
-Implementation of overall GMP assessments & oversight in assigned GMP areas.
-Review PD, MBR, Specification, Analytical procedure and other GMP document.
-Approve operational level SOPs/ Qualification documents
-Participation for audits as well as support of the experts in answering audit findings
-MSO(Management System owner)& local SOP owner
-Keep improving system quality and attainability.
-Provide training to system users.
-Aligning with BI global/ BI bio procedures and authority guidance, e.g. FDA, CFDA, EU, ICH, etc.
-Participate in the audit as the system owner/SOP owner as well as answer audit findings.
-Retrieve KPIs for QMR
-Take the role of assigned local management system owner and/or local SOP owner to continuously improve the local quality management system, and support creations and revision of Biopharma Division Procedure.
-Deviations/CAPA/Complaint/Investigation
-Ensure that the quality aspects of the deviation/CAPA/Complaint/investigation comply (contents, clarity, completeness).
-Support of the lead investigators.
-carry out assigned deviations as Lead Investigator
-Participation in Deviation & CAPA board
-Prepare and distribute status reviews on deviations/CAPA/Investigation.
-For systematic deviations, create a further CAPA with the experts.
-Plan and carry out effectiveness check of CAPA.
-Monitoring/trending of deviations
Change Management
-ensure that the quality aspects of the change requests comply (content, clarity, completeness)
-support for submitting the change request
-release of the change request for implementation
-definition and implementation of Effectiveness checks
-support the change and follow up the timely closure of change
Batch Record/Analysis Reports/GMP Documents Review
-Carrying out DS Batch Record and Analysis Reports Review.
-Oversight GMP documents generation e.g. SOPs, MBRs,Risk Assessment etc.
-Responsible for answering customer comments during BR and Analysis Reports review,coordination with the experts.
-Work within QA management to contribute to other QA related work packages, e.g. qualification, Training, per business needs.
-Lead Quality Risk Management
-Lead the compilation of APR/PQR
-Review Risk Assessment
-Support the investigation of complaint
-Support the handling of complaint/recall.
Any other task assigned by line manager
Processes/ BPE
-to ensure continual improvement of processes and work sequences within processes and for the interfaces
-continuous critical review of the respective Status Quo in regard to the diverse KPIs and also the process parameters, to improve our daily work sequences
-participation as core team member or expert in the various Streams/Initiatives
Requirement
-Bachelor degree on Pharmaceutical, Biopharmaceutical, Chemistry, Analytical
-Language skills & proficiency: Fluent in reading, and good in spoken and written.
Skillful in using office application software (MS-Word, MS-Excel, MS-Project, MS Power Point, MS-Outlook).
-At least 8 years related working experience in GxP system as well as experience in working on an international level.
-Experience in authority inspections and corporate audits
-5 years of team management experience.
-Excellent communication skills, persistence, commitment.
-Rapid learning ability, high level of energy and self-motivation.
-Organized analytical thinker attention to detail.
-Inter-cultural competence, be culturally sensitive and diplomatic.
-Ability to work independently and flexibly.
-Good GMP regulation expertise include FDA, EMA and NMPA
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.