7 years pharmaceutical quality assurance experience
Aseptic filling operations expertise
Fda/eu cgmp regulatory knowledge
The role involves providing quality oversight and immediate support during project phases and routine GMP operations including aseptic filling and material release
Job Summary
The role involves providing quality oversight and immediate support during project phases and routine GMP operations including aseptic filling and material release.
Candidates must possess at least 7 years of experience in pharmaceutical quality assurance with specific expertise in aseptic filling and new facility startups.
Roche fosters a culture of personal expression and genuine connections where every voice matters to prevent, stop, and cure diseases.
Matching Summary
The role involves providing quality oversight and immediate support during project phases and routine GMP operations including aseptic filling and material release.
Skills & Requirements
Must-have
7 years pharmaceutical quality assurance experience
Aseptic filling operations expertise
FDA/EU cGMP regulatory knowledge
New facility startup and ramp-up experience
Risk assessment and mitigation strategies
Deviation investigation and CAPA implementation
Nice-to-have
Auditor training certification
Multinational company background
International regulatory network exposure
Continuous improvement technology implementation
Diplomatic communication with diverse personalities
Key Requirements
Degree in pharmaceutical sciences or related discipline
Minimum 7 years QA/GMP experience
Fluent English communication skills
Experience with ICH guidelines and FDA/EU regulations