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Pharma Quality Assurance Engineer
Location:
US-TX-Austin - 78734
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(E-CQR, Inc. has an opening in Austin, TX) Pharma Quality Assurance Engineer: Execute validation protocols per SOPs in the pharmaceutical industry and assure acceptance criteria are met. Develop Qualification Master Plans, process flow diagrams, test cases, and SOPs. Develop qualification documents, Functional Design Specifications, Test Protocols (IQ/OQ/PQ), and summary reports, supplementing documentation provided by Suppliers/Contractors/OEMs. Review qualification or test plans issued by Suppliers/Contractors for completeness and correctness. Interface with Quality Assurance and R&D on process requirements for current products. Assist with on-site transfer projects and product scale up activities. Recommend improvements in manufacturing and control systems. Assure protocols are approved through proper channels. Write and revise validation protocols. Assure test data is gathered and recorded in accordance with cGMP requirements. Analyze data to ascertain if it meets related protocol acceptance criteria. Write deviation reports as required upon failures to meet protocol acceptance criteria. Write reports and assure they are approved through proper channels. Provide support in investigations and other troubleshooting activities. Develop and communicate project timelines and status. Comply with GMP and safety requirements, SOPs, and company policies and procedures. Requires less than 5% domestic travel. Requires Bachelor’s in Pharmaceutical Sciences or related and 1 year experience. Send resume to hr@ecqrinc.com.

HR
E-CQR INC.
1213 Ranch Road 620 South
Suite 201
Austin, TX 78734

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