Role DescriptionYou are able to think out of the box for this role. You also have good interpersonal, verbal and written communication skills in English A team player with a can-do attitude. Comfortable in a fast-paced Multinational environment with minimal direction and able to adjust workload based upon changing priorities
ResponsibilitiesReceipt and disposition of incoming materials (if applicable). Ensures that associated CAPAs are initiated and resolved, as needed. Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes. Contribute to the maintenance and reporting of metrics related to batch record review and product disposition in support of the Management Review. Contribute to the development and implementation of Quality on the floor processes, including batch record review, and deviation handling. Review batch-related documentation, and ensures resolution of issues to release product. Perform preparations for product disposition/lot closure by the QP. Ensure all product-related Deviations are initiated, investigated and resolved. Apply lean thinking to ensure continuous improvement project. Intake and handling of product complaints for EU and/or related investigations. Assist with implementation and maintenance GMP training system in EU. Support inspection readiness plans and interact with regulatory agencies during inspections as needed. Oversee the packaging and shipping process for EU. Oversee the product disposition process for EU.
RequirementsMinimum of 2 years’ progressive quality or manufacturing experience in a pharmaceutical, biotech, or biologics operation Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards Strong knowledge of GMP, including GDP and preferably Lean principles.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.