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QA Batch Record Auditor Saint Albans City United States,  


Posted on : 08 May 2017

Project Description

Tracking Code 2015913 Job Description Perrigo Company plc is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription (Rx) pharmaceuticals, nutritional products, and active pharmaceutical ingredients (API). The company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market and an industry leader in pharmaceutical technologies. Perrigo Nutritionals, located in Georgia, VT, is looking for a Batch Record Auditor to their Quality Assurance team.The Batch Record Auditor will be responsible for reviewing batch records and resolving non-routine exceptions and accompanying paperwork to assure that batches were produced in compliance with cGMP’s and to assure that the product meets current acceptable specifications. Major Duties/Responsibilities: Review batch records to ensure that batches are manufactured and/or packaged according to approved SOP’s. Assure that specified sampling and testing is complete, acceptable, and accounted for prior to batch disposition, and that cGMP errors are resolved and quality incident investigations closed out.    Verify SAP batch information is accurate, and correct if needed. Verify accuracy of SAP inventory, and perform split batch transactions when required. Perform batch releases in SAP and file batch records. Work closely with internal, as well as sub-contract manufacturing Production, Packaging, QC and QA personnel to address production and testing concerns.   Follow cGMP’s, SOP’s and Work Instructions. Performing quality incident investigations. Other duties as assigned. A successful candidate will have: Ability to work independently and/or with minimum supervision against multiple deadlines.  Excellent oral and written communication skills, and strong interpersonal skills. Strong attention to detail. Strong analytical skills.  Excellent multi-tasking skills and flexibility to handle changing priorities. Required Experience High school diploma or GED, advanced education preferred. Consideration may be given to those who hold 6 years of progressively responsible and relevant work experience. Minimum of 1 year experience in Quality and Operations. Minimum of 3 years experience working in FDA regulated industry. Preferred Experience Possess an understanding of and ability to apply cGMP’s. Must be able to recognize variances from cGMP’s.  Thorough knowledge of SOPs and be able to provide clear direction and interpretation to staff in multiple areas.   Thoroughly understand equipment operation and manufacturing/packaging processes.  Demonstrates a thorough working understanding of the interactions of complex business and compliance practices and requirements. An Equal Opportunity Employer - M/F/D/V Internal applicants can apply by end of day May 10, 2017 to be considered. Internal applicants' direct supervisor and senior management will be notified by the talent acquisition team upon candidacy.  Job Location St. Albans, Vermont, United States Position Type Full-Time/Regular

Locations

St. Albans Vermont United States

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