Collaborate with key stakeholders including manufacturing operations, supplier quality, quality systems and Planning; provide Quality oversight in Drug Products life cycle and the E2E manufacturing process
Job Summary
Collaborate with key stakeholders including manufacturing operations, supplier quality, quality systems and Planning; provide Quality oversight in Drug Products life cycle and the E2E manufacturing process.
Ensure on-time batch disposition per the requirement of Roche Timeline and that products are not sold or supplied before a QP/AP has released.
Execute QA process/documentation maintenance in a continuously compliant state and a continual state of readiness for regulatory agency inspections.
Matching Summary
Collaborate with key stakeholders including manufacturing operations, supplier quality, quality systems and Planning; provide Quality oversight in Drug Products life cycle and the E2E manufacturing process.
Skills & Requirements
Must-have
Quality oversight in Drug Products life cycle
Frontline QA activities in plants
Batch release process
API/direct materials management
Quality system oversight
cGMP relevant to the pharmaceutical industry
Nice-to-have
Encourages personal expression
Open dialogue
Genuine connections
Advance science
Deliver life-changing healthcare solutions
Key Requirements
Bachelor Degree (4 years education of Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent)
5 or more years’ work experience in the pharmaceutical or related industry
3 or more years’ experience in a commercially licensed GMP facility