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Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA). Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams.
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Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOP’s), authoring and executing Risk Mitigation Plans as needed.
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A minimum of five (5) years’ experience in pharmaceutical, biologics, biotech or related industry with relevant experience. B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent.
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Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA's) and provide direction and recommendations as to future course(s) of action.
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Monitors data clean-up process performed by CRO's from study start-up through data archiving. Monitors data clean-up process performed by CRO's from study start-up through data archiving. Experience with JMP and SAS a plus.
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Implements procedures and processes for the dissemination of data and information and means for the archiving of data. Develops, documents, maintains, and implements policies and procedures to ensure the integrity and security of the SAP BASIS System.
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Email Management: Manage email accounts, including setting up email forwarding, archiving, and retention policies. Email Management: Manage email accounts, including setting up email forwarding, archiving, and retention policies.
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Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization, Manufacturing, Packaging launch teams. Our triumphs are a testament to our ability to assemble teams of forward-thinking, innovative, and passionate professionals who collectively propel us to new horizons.
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Identify, label and prepare study related documents, folders and test materials for archiving. Prepare and maintain necessary forms and database for archiving and retrieving test materials and study documents.
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We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants. Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate CLIENT and FDA and European Medicines Agency (EMA) cGMP regulations and policies.
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