GMP AuditorVerified as a real position
Zentiva
Czechia, Praha8 days ago
- Posted
- Employment type
- Full-time
Salary range
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FarmacieSeniorGMP/GDP auditAnalytické myšleníAngličtinaPraha / Bukurešť
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Who we’re looking for
- 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
What you’ll do
- 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.
About the position
Act as an independent Quality Systems Auditor, provide an independent assessment of Quality Management Systems of audited Zentiva third parties (CMOs, material and service providers).