Quality Disposition Assoc III - EMQO
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POST DATE 9/9/2016
END DATE 10/12/2016
JOB DESCRIPTIONAPPLY Department Name
RTP EMO QA
Performs Label, Master Batch and Lot Record Review and Approval
Reviews executed production records and assigns the appropriate Disposition
Conducts and documents investigations into deviations or complaints
Authors/prepares Annual Product Reviews/Product Quality Reviews
Provides support for Regulatory Agency audits
The position independently determines whether the product manufactured by Eisai meets standards and is acceptable for distribution to Eisai Patients.
Bachelor s degree (preferably in science related discipline)
8+ years of pharmaceutical/biotech experience
Strong oral and written communication skills.
Ability to interpret and apply GMPs, relevant laws, guidance documents and directives to extremely complex pharmaceutical situations.
Attention to detail, ability to coordinate investigations with multiple functional groups with a sense of urgency.
Exercises independent judgment in evaluating product disposition.
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Eisai is an Equal Opportunity Employer Minority / Female / Disability / Vet