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5+ years of experience validating manufacturing equipment in an industrial/GMP environment. If so, then join our growing team as a Validation Engineer and play a vital role in safeguarding the integrity of our pharmaceutical products.
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4 to 5 years of relevant industry experience in Chromatographic analysis (HPLC) in a GMP environment. We are seeking a Chemist to our Analytical Development & Testing department (ADT) here at Recipharm RTP. The level of the position will be based on qualifications and experience.
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Bachelors or Masters graduate with 2 years of GMP experience and skills in SOP and batch record review. Activities include but are not limited to a review of GMP raw data for compliance.
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Advises internal teams on the application of drug and device laws and regulations, as well as Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Good Pharmacoepidemiology Practice (GPP) as well as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) as they relate to clinical research.
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Extensive knowledge of applicable regulations, including GMP and food safety standards in accordance with the FDA, USDA and CFIA. HACCP certified, SQF Practitioner and PCQI certified or ability to obtain certification within 6 months of starting role.
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Ensure all GMP documentation is filled out correctly and is legible. Job Summary: The Logistics Coordinator is responsible for receiving, scheduling, and preparing Change of Custody events. Logistics Coordinator I.
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Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing Directions. Ensures manufacturing line is operating at optimum level for a GMP environment in a Safe mode while meeting production goals.
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The GMP Tech will be responsible for keeping assigned areas within GMP in clean and orderly condition. Perform sanitization duties to maintain a GMP controlled environment. Perform repetitive tasks in a GMP environment.
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Adhere to GLP and GMP guidelines as required to maintain a compliant, safe and clean work environment. Adhere to GLP and GMP guidelines as required to maintain a compliant, safe and clean work environment.
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The Metrology Engineer position involves a range of responsibilities within a GLP/GMP environment. Experience - 4+ years' experience within a GLP/GMP Environment, laboratory experience. Must be familiar with basic GLP/GMP policies and guidelines and understand how their role impacts compliance.
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Knowledge of FDA and/or GMP regulations is preferred. Assist with manufacturing deviation analysis, CAPA actions, and other process equipment-related quality concernsMaintain all work areas in a well-organized, clean, and tidy manner at all times in compliance with cGMP requirementsOperate cleaning equipment, and utilize SOP and documentation to record data manually or through identified software applications.
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General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA. Context, Environment, & Safety This position will have up to 100% travel to the site, or as required by the assigned project.
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