The External QUALITY Specialist is responsible for ensuring that all company products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with company’s expectations and all applicable regulatory requirements. The candidate will have responsibility for External Party / External Partner (EP/ExP) operations related to the quality of products produced, under the oversight and guidance of the Product Quality Manager Lead – EQA. Role has primary batch release responsibility. The candidate will ensure that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the EP/ExP’s manufacture and release of (API intermediates, API) by means of risk-based quality oversight and on-site supervision, as appropriate.
• Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of the company and compliance with all governing regulations; review and approve changes to master batch records.
• Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer.
• Provide guidance to the partner on conducting investigations of batch rejection, atypical events, customer complaints, etc. where warranted.
• Provide support for audits of EP/ExP by the company and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted.
• Support routine analytical change requests and support process modification change controls.
• Annual Product Review assembly.
• Support document requests for regulatory filings and post approval changes.
• Gap remediation plans, Quality Risk Management data inputs, and data integrity gap assessments.
• Receive and share Quality Alerts and Quality Bulletins with EP/ExP.
• Closely collaborate with appropriate business/operations and technical areas to achieve company objectives.
• Ensure both operational knowledge and technical skills are maintained and compliant against individual training requirements.
• BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
• Minimum of 5 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
• Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem-solving capabilities.
• Possess a combination of analytical/scientific skills in order to effectively manage and control all activities necessary to support a total Quality Operations program governing external parties/partners that manufacture, package, analyze, release, store and/or distribute company product.
• Experience in SAP and Trackwise.
• Thorough knowledge of all aspects of EM management, supply chain, and operations.
• A broad knowledge of manufacturing operations, including engineering, materials, R&D, production, etc.
• Lean Six Sigma / company Production Systems training.
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