Not specified (assumed to be hybrid or onsite based on the nature of the role).
7 years pharmaceutical qa or qv experience
Aseptic filling facility experience required
New dp facility startup readiness
Roche is seeking an Associate Manager for Qv Biologics in Shanghai, China, focusing on quality assurance and validation within the pharmaceutical sector. The role requires significant experience in QA/QV, particularly in aseptic filling and compliance with regulatory standards
Job Summary
The role ensures project performance aligns with Roche Standards, Good Practices, and regulatory requirements including Annex 1 and GAMP 5.
Candidates must oversee the strategy and execution of Commissioning and Qualification activities while representing Quality Assurance in design reviews.
Roche fosters a culture of personal expression and genuine connections where every voice matters in preventing, stopping, and curing diseases.
Matching Summary
Match Score: 85
Roche is seeking an Associate Manager for Qv Biologics in Shanghai, China, focusing on quality assurance and validation within the pharmaceutical sector. The role requires significant experience in QA/QV, particularly in aseptic filling and compliance with regulatory standards.
Skills & Requirements
Must-have
7 years pharmaceutical QA or QV experience
Aseptic filling facility experience required
New DP facility startup readiness
GMP standards knowledge ISO FDA ICH ISPE
Commissioning qualification lifecycle URS IQ OQ PQ
Nice-to-have
Auditor training certification advantageous
Multinational company background preferred
Risk-based approach to validation
Diplomatic communication with stakeholders
Process improvement recommendations
Key Requirements
Degree in pharmaceutical sciences or related discipline