We are working with a global pharmaceutical manufacturing company to recruit a Manufacturing Specialist. The Manufacturing Specialist will be responsible for leading deviation investigations across fill/finish, inspection, and packaging operations. The role requires applying strong technical, quality, and compliance expertise to ensure thorough investigations, effective CAPAs, and regulatory readiness in a fast-paced manufacturing environment.Key ResponsibilitiesLead end-to-end deviation investigations, including team coordination, root cause analysis, product impact assessments, CAPA development, and compliant documentation.Drive timely execution of investigations, ensuring clear communication of progress, risks, and outcomes to stakeholders and leadership.Facilitate and lead cross-functional teams to resolve complex issues, applying structured problem-solving methodologies.Present investigation findings to regulatory inspectors and internal auditors, ensuring clarity, accuracy, and compliance.Identify and implement continuous improvements to investigation processes, enhancing efficiency, quality, and compliance standards.Key RequirementsDegree in Science or Engineering (or equivalent experience) with significant experience in biotech/pharma manufacturing or support functions.Strong technical knowledge of fill/finish operations and GMP-regulated environments.Proven experience leading complex investigations, including root cause analysis, CAPA management, and quality systems.Excellent communication, presentation, and technical writing skills, with the ability to convey complex information clearly.Demonstrated ability to manage multiple priorities, work cross-functionally, and operate effectively in a dynamic, fast-paced environment.
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