(Sr) Specialist, QV Biologics (CSV/DI)

Roche(4 months ago)

Shanghai, ChinaOnsiteFull TimeMedior$97,247 - $130,619 (estimated)Quality

About this role

A Quality and Validation Specialist at Roche is responsible for ensuring that qualification and validation programs for drug product facilities meet regulatory and corporate standards. The role focuses on delivering compliance and readiness for new facility startups while supporting cross-functional projects. It contributes to maintaining data integrity and product quality within the manufacturing environment.

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Required Skills

Validation
Qualification
Data Integrity
C&Q
GAMP5
Annex1
Aseptic Filling
GMP
Protocol Writing
Risk Assessment

+4 more

Qualifications

MSc in Biochemical Engineering
BSc in Biochemical Engineering
BSc in Biochemistry
BSc in Applied Science
Auditor Training

About Roche

roche.com

As a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.

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