As Lead QA Technician, you ensure product quality and regulatory compliance within pharmaceutical manufacturing. You will work as part of the Quality team to uphold high standards and support life-changing medicines. Expect to investigate deviations, manage CAPA, and help prepare for regulatory inspections in an aseptic environment. You will collaborate with cross-functional teams to maintain compliant documentation and processes, contributing to the mission of making the world healthier, cleaner and safer. This role offers the chance to shape quality programs in a global, fast-paced setting. * Quality oversight of pharmaceutical manufacturing operations * Batch record review and deviation investigations * CAPA management and effectiveness verification * Support regulatory inspections and customer audits * Maintain and improve quality systems and documentation (TrackWise, Documentum)
* Collaborate with cross-functional teams to address quality issues * Ensure aseptic manufacturing processes and clean room controls * Communicate findings clearly and drive corrective actions * Guide and develop team members on quality practices * Manage multiple priorities in a dynamic environment * 4 years of experience in pharmaceutical quality assurance or related GMP environment * Comprehensive knowledge of GMP regulations, FDA guidelines and quality systems * Experience with batch record review, deviation investigations and CAPA management * Strong understanding of aseptic manufacturing processes and controls * Advanced proficiency in quality documentation systems (e.g. TrackWise, Documentum) * Professional communication skills (written and spoken) * Ability to manage multiple priorities and work under pressure * Strong attention to detail and analytical problem-solving skills * Interpersonal and communication abilities; project management and organizational capabilities * Experience supporting regulatory inspections and customer audits * Cross-functional team collaboration * Pro
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