Senior QA Scientist

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

• Execute QA operational tasks according to the agreed upon execution plan and timeline, e.g. but not limited to documents (Deviation, CAPA, Change Control, Investigation and etc.) initiation/follow up, reports/presentations, batch record review and batch release.
• Provide active oversight and take ownership responsibility to the Bio Shanghai site quality system by aligning with Boehringer One Quality strategy.
• Perform end to end GMP Duties & Oversight on GMP activities of assigned GMP areas (e.g. DP area, QC microbial testing related to DP).
• Take the role of QA Business Partner to ensure that the quality aspects of the deviation/CAPA/OOX comply (contents, clarity, completeness). Support of the lead investigators. Review and approve investigation report. Make sure the requirements of compliance are met.
• Review and approve CAPA report. Make sure related corrective and preventive actions are completed reasonably. Plan and carry out effectiveness check of CAPAs.
• Batch Manufacturing/ Analysis Reports Review. Carrying out the Batch Manufacturing/Analysis Reports Review. Carrying out the Batch Manufacturing/Analysis Reports Review with customers.
• Take the role of assigned local SOP owner to continuously improve the local quality and support creations and revision of Biopharma Division Procedure. Establish and review workflows for SOP and other GMP documents.
• Acutely identify system weaknesses and gaps as QA system owner with applicable solutions; be capable of efficiently solving identified issues.
• Assure quality compliance of all GMP manufacturing relevant activities; provide support to the other department interfaces from the GMP perspective under NMPA, FDA, EU and ICH guidance and Boehringer internal guidance. Participate in audits/inspections as well as support of the SME in answering audit findings.
• Continuously and proactively acquire knowledge from daily tasks, training and Boehringer global network. Establish an applicable and efficient strategy for knowledge management.
• Act as a good role model and coach junior team members and new employees when necessary to meet team targets. Continuously support stakeholders for improvement and show good communication skills /cooperation mindset.
• Work within QA management to contribute to other QA related work packages, e.g. qualification, Training, per business needs.

Qualifications

• Bachelor degree or above for Biochemistry, Chemistry or Biopharmaceutical.
• 8 years of experience in pharmaceutical industry including at least 5 years in aseptic manufacturing and/or sterility testing experience.
• 5 years or above QA relevant experience in GMP.
• Biopharma manufacturing and QC microbiological knowledge and experience, especially aseptic product manufacturing knowledge, CCS risk assessment, sterility testing; GMP regulation expertise include FDA, EMA and NMPA.
• Language skills & proficiency: Fluent in reading, and good in spoken and written.