Quality Assurance Specialist
Shanghai, 中华人民共和国 Bachelor's Degree Design / Civil engineering / Industrial engineering
Job description
3227790
Additional Cities
Shanghai
Career Level
Experienced
Relocation Assistance
No
Business
GE Healthcare
Business Segment
Healthcare Life Sciences
Function
Quality
Country/Territory
China
Additional States/Provinces
ShangHai
Postal Code
201203
Role Summary/Purpose
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.
Essential Responsibilities
1. Maintain and update the QMS system to support pre-clinical and clinical biosimilar manufacturing service.
2. Audit manufacturing area according to QMS, equipment logbook, material logbook, batch records and so on.
3. Management of the SOPs (Creation, translation, distribution, checking, updating and destroy)
4. Management of manufacturing batch records, including checking, approval, release, distribution, collection, updating and archive.
5. Follow-up of equipment calibration and IQ/OQ with vendor or government authority.
6. Investigate all the out of specification (OOS) and deviations, prepare Corrective Action & Preventive Action (CAPA) and follow up.
7. Be responsible for releasing Bulk Drug Substance (BDS) and Drug Product (DP) for PK/PD and Tox animal study, based on QC report.
8. Align and update GE QMS with customer’s requirement to meet IND and clinical phase requirement.
9. Audit third party CRO company QMS and support vendors to improve the system and meet IND and clinical phase requirement.
10. Training and accreditation of the staff in quality.
11. Support lab technician, sourcing and EHS to manage raw material, such as lot control, sample logbook management and MSDS management
Qualifications/Requirements
• 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.
Desired Characteristics
• 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.
About Us
GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com
Primary Country
China
Primary State/Province
Shanghai
Primary City
Shanghai