Gmp Auditor

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

MISSION STATEMENT

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).

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.

OTHER RESPONSIBILITIES- QUALITY: Adhere to the principles of GMP and GDP in the extent related to the performed activity. Is obliged to regularly train in these policies.- HSE : Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.- PHARMACOVIGILANCE: All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations.- COMPLIANCE: The employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents.