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3+ years of proven experience in a buyer/planner role (cGMP experience preferred). ERP / EIS tactile execution in a cGMP facility. Demonstrated working knowledge of working in a cGMP facility preferred.
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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide.
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Perform "Data Integrity” related- risk assessments, deviation investigations, implement remediations in cGMP operations. pharmaceutical and cGMP operations for a key client. Extensive experience with all pertinent industry best practices (e.g., ISPE GAMP5) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report.
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Bachelors in STEM Discipline (Chemistry focus preferred) and at least 3 years of experience in cGMP manufacturing. Familiarity with cGMP manufacturing environment and terminology. Master's Degree and 1 year experience in cGMP manufacturing.
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Develop and implement the management of Group and site-specific Quality Management Systems (QMS) meeting cGMP requirements including SOPs, client-specific procedures, and safety training programs.
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5-7 years of experience in validation engineering in the life science industry and cGMP environments. Responsible for protocol writing and execution - draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.
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Prior experience in engineering and maintenance of a cGMP plant, including design of facilities according to Lean concepts in material, people, and waste flows, preferably in aseptic manufacturing and radiopharmaceutical processing.
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PRD QA Clinical Trial (CT) Packaging is responsible for oversight of packaging and release of finished goods material within PRD and assures compliance with quality systems and current Good Manufacturing Practices (cGMP.
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Validation documentation to ensure products are manufactured in accordance with cGMP, pharmaceutical regulatory agencies, manufacturer, and Cardinal Health. Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Chemistry, Metrology or related science field, or equivalent work experience preferred.
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Strong knowledge of CGMP and quality systems with a minimum of 5 plus years of direct CGMP experience. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities.
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This leadership position will play a crucial role in rapidly scaling our growing platform in this underserved market by leveraging Langham's state-of-the-art network of cGMP facilities and extensive experience in cold chain transportation services.
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During your time with us, you will have the opportunity to perform layout and design of HVAC systems for pharmaceutical and life sciences meeting standards for current Good Manufacturing Practice (cGMP) applications and other process related facilities.
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Advises from a cGMP perspective, the functional areas on strategies for the life cycle management of data residing within computer systems (i.e. collection, storage, maintenance, backup, recovery, archival, retirement.
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Responsible for participating in continuous training: cGMP training, technical skills, safety, performance improvement. Review change to cGMP documentation and re-train. The Floater micro-cleaner is a critical role in the company which ensures the proper cleaning of the cleanroom, controlled environment and GMP laboratory environments in the Indiana area.
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Knowledge of regulatory requirements, quality systems, and industry standards (e.g., cGMP, USP, EP) governing analytical instrumentation in the pharmaceutical industry. Instrumentation Program Management : Develop and implement an instrumentation program to manage the calibration, qualification, and maintenance of analytical instruments and equipment used in pharmaceutical manufacturing and quality control laboratories.
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