GMP Auditor
Zentiva · Prague
Are you an experienced GMP/GDP Auditor looking for a role where you can combine your quality expertise with international travel and real influence?
Join Zentiva as a Quality Systems Auditor and become our trusted expert assessing the quality systems of manufacturing partners, suppliers, and service providers across Europe and Asia. You'll conduct independent GxP audits, drive continuous quality improvement, collaborate with global stakeholders, and help ensure patients receive high-quality medicines.
If you're passionate about pharmaceutical quality, enjoy working independently, and are ready to travel internationally while making a tangible impact, we'd love to hear from you.
MAIN ACCOUNTABILITIES AND DUTIES
- To act as qualified GxP auditor based on the Zentiva internal and third party audit plan.
- To negotiate the audit date with auditee
- To prepare data for the audit
- To manage the audit trip
- To carry out the audit
- To write the audit report and ask for CAPA proposal
- To check and confirm the CAPA proposal
- To follow up CAPA if needed
- To manage all audit documents in TrackWise and other systems
- To review the audit reports done by the external companies and manage them in TrackWise.
- To participate in trainings/self-trainings.
- To help set up the Zentiva auditor training process and participate as the lector.
- To prepare and justify regular reporting in respective area.
- The employee will perform other tasks under the direction of the Manager within the agreed type of work.
REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS
- University education (pharmacy, chemistry, pharma technology, biology etc.)
- English language in writing and speaking, other language is the advantage (Czech is not mandatory)
- Microsoft Office – Excel, Word, Outlook
- Experience in pharma industry or quality lag is a must
- Experience as the GMP / GDP auditor at least two years
- Experience with TrackWise is the advantage
- Ability to learn / quick adaptability / analytical / organized / communicative
- To follow requirements of solid line manager and job description.
- To follow tasks and timelines, set for particular activities and projects.
- To work independently, to be proactive.
- Ability to travel worldwide esp. Europe and Asia (up to 70% of working time)
- Certification as GMP auditor (ECA, IRCA …) is an advantage
- Driving license B – active driver
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