GMP Quality Coordinator
3 days ago
Lonza is committed to making a positive impact on millions of people worldwide through innovation, quality, and customer satisfaction. We strive to create a dynamic and challenging work environment that allows our employees to grow professionally and personally.
Job Details
This role involves providing oversight into manufacturing in a large-scale, multi-product, GMP biotech contract manufacturing facility. As a QA Specialist, you will support day-to-day QA activities, ensure process awareness, review and approve SOPs, protocols, reports, and records, troubleshoot issues, lead small projects, build strong working relationships with internal and external customers, plan and coordinate future activities with other departments, develop into a qualified trainer, review batch records, raise deviations, compile lot genealogy, escalate process events, support changeover activities, detect non-compliance with cGMP/GDP, provide corrective guidance, participate in walkdowns, audits, and provide feedback for improvement, lead or participate in deviation investigations, change controls, and CAPA plans.
Requirements
To succeed in this role, you will need a degree from a recognized institution with 3-5 years' experience in a similar type of industry or a similar job role, or a diploma with 5-7 years' experience in a similar type of industry or a similar job role. Familiarity with regulatory requirements and local codes & standards is also essential. You should have fair knowledge and experience of the practical and theoretical requirements of quality management systems in a GMP facility. Additionally, you should be meticulous and systematic, a team player with a strong focus on safety, quality, and timelines, and able to operate independently with minimum supervision.
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