GMP AuditorOvěřeno, že jde o reálnou pozici
Zentiva
Česko, Prahapřed 9 dny
- Zveřejněno
- Typ úvazku
- Plný úvazek
Platové rozmezí
Získej přístup k AI odhadu mzdy
Odemkni odhad mzdy a zjisti, jak si stojí tato pozice na trhu.
FarmacieSeniorGMP/GDP auditAnalytické myšleníAngličtinaPraha / Bukurešť
Získej víc odpovědí od zaměstnavatelů
Pošli zaměstnavateli životopis na míru během pár minut.
Koho hledáme
- 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
Co budeš dělat
- 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.
O pozici
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).