Job description
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 Track.
Wise and other systems To review the audit reports done by the external companies and manage them in Track. Wise. 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 Track.
Wise 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