GMP Auditor

Requirements

• University degree in pharmacy, chemistry, life sciences, engineering, or related field
• 5+ years of experience in GxP / Quality, within the pharmaceutical industry is required
• Strong knowledge of GMP, regulatory requirements, audits, deviations, and change control
• Proven experience in conducting external audits, with a minimum of 20 audits performed at pharmaceutical drug manufacturing sites
• Experience with internal and external audits, and inspections
• Excellent analytical, communication, and stakeholder management skills
• Ability to work independently in a complex, matrix environment
• Fluent English (written and spoken)

Benefits

Additional Information

Locations : Czech Republic, Romania, Bulgaria, Poland Zentiva is a leading European pharmaceutical company committed to delivering high-quality, affordable medicines. Quality, patient safety, and regulatory excellence are at the core of everything we do. We are looking for an experienced GMP Auditor to join our Corporate Quality team. In this key role, you will help govern critical quality incidents, ensure consistent escalation and reporting across Zentiva, and strengthen compliance with global regulatory and GMP requirements. You will act as a trusted quality partner across manufacturing sites, affiliates, and external partners. Main Responsibilities Lead and manage quality escalations, including assessment, categorization, mitigation, and Health Authority communication Provide expert guidance on external audits and regulatory expectations Plan, conduct, and document independent audits in compliance with Zentiva's Quality System and applicable regulations Act as a liaison between Quality and business stakeholders to ensure effective issue resolution Support regulatory surveillance and Health Authority reporting Design and conduct risk-based external audits (CMOs, suppliers, service providers) Drive continuous improvement of quality systems, processes, and documentation Contribute to corporate quality governance, training, and knowledge sharing Traveling within Europe up to 75%

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