About the Role
Description
Key Responsibilities:
Apply critical thinking and risk-based judgment to address routine and complex manufacturing challenges, and ensuring continuous improvement.
Review and approve documentation and records related to drug substance manufacturing activities, including batch records, materials management, cleaning, and analytical data.
Provide support for manufacturing investigations, including deviations, CAPAs, and change controls associated with production processes.
Participate in authoring, reviewing, and approving SOPs, forms, and controlled documents to ensure compliance with GMP requirements.
Provide QA oversight during manufacturing operations and collaborate with cross-functional teams to resolve issues promptly.
Support internal and external audits, inspection readiness, and continuous improvement initiatives at the site.
Activ...
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