Primary task is BRR, eventually once familiarized with role and BRs of contract mfgs, then they will train on BR disposition to release finished goods. Will also train on OL responsibilities once up to speed. Will also be trained on labeling requirements and master BRs.
She will be paired with an QA OL to provide this 1:1 training.
No deviation, CAPA, investigation experience required coming in, but would be a nice to have.
Communication with CMO is a nice to have.
Role and Responsibilities:
• Review and approve master batch records, labels, specifications and other pre-production documents for Clinical/Commercial Drug Product in compliance with FDA and international health agency requirements.
• Review executed production batch records, environmental monitoring data (as required), and associated documentation, including any deviation and investigation reports related to lot release of Clinical/Commercial Drug Product in support of product disposition.
batch record review, Gmp, Quality assurance, pharmaceutical
Top Skills Details:
batch record review,Gmp,Quality assurance,pharmaceutical
Additional Skills & Qualifications:
• Good working knowledge of Quality Systems, FDA/EMEA Standards, current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
• 4+ years of relevant experience in a GMP environment-related field and a BS OR 2+ years of relevant experience and a MS.
• Prior experience in pharmaceutical industry
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