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Validation Specialist
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- Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules.
- Reporting to the Senior Manager, Engineering ,
- Gathers photocopies and compiles relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw materials certificates of analysis.
- Interacts with and coordinates compliance efforts with other departments including, but not limited to:Operations, Engineering, QA, QC laboratories and Tech Services to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
- Writes validation protocols (commissioning/ qualification, PQ, and Controls) for facilities, manufacturing equipment, manufacturing processes, cleaning, and critical utilities.
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