Tunnell Consulting

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OPS. Batch Review

at Tunnell Consulting

Posted: 6/25/2019
Job Reference #: 9162
Categories: Other/General
Keywords: commercial

Job Description

Operations Batch Review is primarily responsible for the review of the executed batch records for manufactured drug products for commercial distribution.  This position will be independent of the Quality Assurance review and must have an understanding of the implications of the work and knowledge of the context in which the work is being performed.  The Ops Batch Review position is responsible for conducting a technical and compliance reviews in accordance with current Good Manufacturing Practices (CGMPs), FDA regulations and Standard Operating Procedures (SOPs). This position may also help with the prepping of issues batch records for production use.   

• Experience in quality reviews of manufacturing and packaging batch records for bulk and finished packaged product for final disposition of lots
• Attentive to detail, able to recognize critical attributes, steps and functions relating to manufacturing processes and/or laboratory activities
• Knowledgeable of cGMPs and application of good documentation practices within pharmaceutical industry