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Complete documentation and supporting data per cGMP policies, procedures, and guidelines. We strive to have a remarkable impact on peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
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Complies with cGMP, EHS guidelines, and all working procedures assigned to the position. The Regulatory Affairs Associate is an exempt position that is paid semimonthly. Job Title: Regulatory Affairs Manager.
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Assists in the transfer of technology from Process Development to cGMP Manufacturing. Completes Batch Records and other cGMP documentation accurately and in a timely manner. Must comply with company policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.
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A minimum of 10 years of process engineering design experience in cGMP, FDA, or other regulated manufacturing environments. Subject-matter expertise in cGMP regulations and standards (preferred.
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Complies with all safety, cGMP and Company policies, practices and procedures. Knowledge of biotechnology operations such as, Aseptic Filtration Systems, Fermentation. Fermentation and harvest.
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Experience implementing and managing FDA Good Manufacturing Practices (GMPs)and cGMP, Hazard Analysis and Critical Control Points (HACCP)and HARPC, and reassessment. HACCP, HARPC FSPCA – PCQI Certified.
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10+ years process engineering design experience in cGMP, FDA, or other regulated manufacturing environments. Successfully execute projects that meet cGMP, FDA and other regulatory standards and requirements.
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Solid understanding of cGMP regulations, FDA guidelines, and industry standards relevant to pharmaceutical manufacturing. Design and optimize unit operations including mixing, filtration, purification, and sterilization processes.
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Knowledge of regulated processes (FDA, cGMP, ISO) BS in Business or technical discipline (Engineering, Science, Mathematics, Biomedical science) preferred or at least 5+ years in program management with demonstrated results or equivalent combination of education and experience.
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The right candidate must be familiar with pharmaceutical or related manufacturing processes and be thoroughly familiar with GMP/cGMP regulations (e.g. FDA cGMPs, ICH, IPEC, etc. SQA manages Supplier Audit and Supplier Development programs for customers in many industries including Pharmaceutical, Medical Device, Automotive, Aerospace, and Electronics manufacturing.
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Selection of suitable plasmapheresis donors by performing physical examinations and taking medical histories on all donors through the use of FDA approved Standard Operating Procedure (SOP) Manual, current State and Federal guidelines, OSHA, CLIA, CGMP, all internal company procedures and personal education and experience.
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Ensures the implementation of Standard Operating Procedures relating to the Regulatory Affairs group's activities and compliance with the requirements of Good Manufacturing Practice (cGMP ). Regulatory Affairs Department Manager, Kfar Saba - OSD, Sterile and Biologics.
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Knowledge of cGMP requirements for life sciences projects. Strong understanding and knowledge of life sciences markets and processes (fermentation, cell / gene therapy, API, blood products, purification, fill / finish, medical devices, etc.
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Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for a cGMP operation. Engage and coordinate with other engineering disciplines and other cross-functional departments (Process, automation, building / facilities, procurement, construction management, commissioning, qualification & validation, manufacturing operations, EHS, quality & compliance.
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This individual will be required to work with cross functional teams, including RA/QA and Process Engineering to apply efficient cGMP processes to preserve data integrity and the quality of the drug product, including the safety of all production and non-production personnel.
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cgmp job in Chicago, IL
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