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Responsibilities :

Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products. Assist project teams in planning, preparation, review and approval of quality documentation. Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and/or combination products including compliance with Corporate policies, processes and procedures. Apply effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits. Support the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs. Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates. Support new product introduction for pharmaceutical products, medical devices, or combination products. Support design changes to existing medical devices and combination products. Interact with internal and external partners for development of best practices in our quality systems and procedures. Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system. Oversee the implementation and management of training and education programs for various aspects of quality assurance. Requirements:

5 years relevant experience. BS Degree. Pharmaceutical products, medical devices, combination products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of support may include the Product QA, Manufacturing QA, Supplier/Incoming QA, Process Qualification/Validation, Compendia management and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are following local, Corporate, and governmental regulations. Focus on process qualification PPQ support and review activities on range of topics from process controls to raw material controls. Familiarity with sap, oracle (Inventory management). Will support biologics products (not small molecule products). QA/QC review background. Manufacturing or quality control exp. working with managers in PQA team. Batch records. Overseeing manufacturing process of biologics. Process qualification protocols. 5 yrs exp needed. Document review. Pharma driven candidate needed. Familiarity with Track wise or Veeva exp is a plus. Familiarity with biologics manufacturing (Biologics industry exp needed). Exp with validation documents (process validation documents, method validation documents). Exp with document review and associated skills with that.