General Electric Lead Quality Assurance Specialist in Shanghai, China
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Be responsible for maintaining and improving Quality Management System (QMS) for non GMP (pre-clinical) and GMP bridge (Clinical Phase) manufacturing service. Collaborate with cell culture, purification and QC team to execute QMS and ensure the consistent quality during bridge manufacturing. Align customer’s requirement and GE QMS in according to CFDA/FDA/EMEA regulations and guideline to support bio-drug IND and clinical phase, mainly biosimilar drug.
Maintain and update the QMS system to support pre-clinical and clinical biosimilar manufacturing service.
Audit manufacturing area according to QMS, equipment logbook, material logbook, batch records and so on.
Management of the SOPs (Creation, translation, distribution, checking, updating and destroy)
Management of manufacturing batch records, including checking, approval, release, distribution, collection, updating and archive.
Follow-up of equipment calibration and IQ/OQ with vendor or government authority.
Investigate all the out of specification (OOS) and deviations, prepare Corrective Action & Preventive Action (CAPA) and follow up.
Be responsible for releasing Bulk Drug Substance (BDS) and Drug Product (DP) for PK/PD and Tox animal study, based on QC report.
Align and update GE QMS with customer’s requirement to meet IND and clinical phase requirement.
Audit third party CRO company QMS and support vendors to improve the system and meet IND and clinical phase requirement.
Training and accreditation of the staff in quality.
Support lab technician, sourcing and EHS to manage raw material, such as lot control, sample logbook management and MSDS management
• Bachelor above, major in Biochemical, Pharmaceutical, Medicine, Biology, Bacteriology, or equivalent.
• At least 3 year working experience in biopharmaceutical industry quality area
• Good knowledge of GMP
• Familiar with related local regulations, CFDA, FDA and EMEA
• Experience in preparing IND and NDA documents.
• Good people skills. Proven ability to work in team environment and able to develop lasting working relationship with customer.
• Excellent written and spoken communication skills in English and Chinese. Excellent computer skills for document management.
• 5+ years industrial experience in MAB biosimilar GMP manufacturing.
• Experience in accompanying and supporting CFDA IND on-site inspection.
• Proven excellence in communication, presentation and facilitation skills.
• Demosntrated ability to deliver results while working on multiple project simultaenously, in a cross-functional team in an international enviorment.
Locations: China; ShangHai; Shanghai
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.