M&s - Quality Design And Qualification Manager- Ifb- Bj
Sanofi
Beijing, China
Fda, ema, and chinese pharmacopoeia regulations
Cgmp biologics design and qualification
Factory acceptance testing (fat), site acceptance testing (sat)
The Quality D&Q Manager IFB ensures compliance with FDA, EMA, and Chinese Pharmacopoeia regulations for equipment design and qualification in IFF, Annex 15 and applicable regulations
Job Summary
The Quality D&Q Manager IFB ensures compliance with FDA, EMA, and Chinese Pharmacopoeia regulations for equipment design and qualification in IFF, Annex 15 and applicable regulations.
This role has overall responsibility for participating in project workstreams, ensuring proper execution of design/qualification/validation strategies as well as providing support and guidance for quality processes and procedures.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Matching Summary
The Quality D&Q Manager IFB ensures compliance with FDA, EMA, and Chinese Pharmacopoeia regulations for equipment design and qualification in IFF, Annex 15 and applicable regulations.
Skills & Requirements
Must-have
FDA, EMA, and Chinese Pharmacopoeia regulations
cGMP biologics Design and Qualification
Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT)
DQ, IQ, OQ and PQ
complex equipment qualification
Project quality team participation
Nice-to-have
Collaborate effectively with peers
Act for innovation
LEAN oriented, problem solving
Open minded and curious
Key Requirements
5-8 years industry experience
Biopharma/regulated industry focus
Commissioning & Qualification experience
Process Validation Lifecycle knowledge
Quality by Design principles
Experience working on large capex projects in Asia