GMP Compliance Coordinator – Manufacturing

Lonza; Geleen; Vor Ort; Confidential; Vollzeit

Benefits dieser Stelle

Agile career

Inclusive workplace

Compensation programs recognizing high

Benefits dependent on role and locale

Zusammenfassung

Lonza Geleen is seeking a Manufacturing Compliance Coordinator to support GMP readiness and quality-assurance activities across Manufacturing, QA and related functions. You will investigate quality events, help strengthen compliance and drive continuous improvement to ensure medicines are manufactured to the highest quality standards.

This site-based role emphasizes real-time collaboration and precise execution to maintain GMP compliance and safety in the production of advanced therapies.

Qualifikationen

• Bachelor's degree or equivalent in Biotechnology, Life Sciences or related field, ideally pharmaceutical.
• Entry-level to early-career experience (up to 4 years) in manufacturing, pharma or biotech environments.
• Good understanding of cGMP in highly regulated environments.

Aufgaben

• Support Manufacturing Compliance Lead in readiness for routine GMP inspections and pre-approval inspections.
• Review and revise batch records, SOPs, protocols, work instructions and other GMP docs.
• Investigate and manage quality events including deviations, change controls and CAPAs with timely closure.
• Collaborate with Manufacturing leads, Production Operators, Biotech Associates, QA and other stakeholders to resolve quality issues and maintain compliance.
• Identify risks to manufacturing delivery and escalate issues with practical solutions within procedures.
• Support internal and external audits and contribute to GMP compliance across Manufacturing.
• Drive continuous improvement in processes, planning and training, and cover for the Manufacturing Compliance Lead when needed.

Kenntnisse

Fluent English

Strong planning

Problem-solving

Collaborative mindset

Attention to detail

Ausbildung

Bachelor's degree in Biotechnology/Life Sciences/related field

Jobbeschreibung

Lonza Geleen is seeking a Manufacturing Compliance Coordinator to support GMP readiness and quality-assurance activities across Manufacturing, QA and related functions. You will investigate quality events, help strengthen compliance and drive continuous improvement to ensure medicines are manufactured to the highest quality standards.

This site-based role emphasizes real-time collaboration and precise execution to maintain GMP compliance and safety in the production of advanced therapies.