Qualification Expert

Qualification Expert - GMP/Pharmaceutical/CSV Automation/Siemens COMOS/EVAL

Project:
We are seeking a highly skilled Qualification Expert to join our clients dynamic team in the pharmaceutical industry. This role involves ensuring the successful qualification and validation processes of embedded Systems.

The perfect candidate is an experienced qualification expert with several years of hands-on experience in qualification within a GMP environment, preferably the pharmaceutical industry

Tasks & Responsibilities:
• Responsible for planning and conducting qualification and validation activities
• Creating and reviewing qualification and validation documents (DQ, IQ, OQ, PQ)
• Carrying out and documenting qualification processes for our Embedded Systems / process automation systems according to cGMP
• Developing, implementing, and conducting test strategies, test plans, and test cases to verify system performance and compliance
• Providing expertise in creating specifications (e.g., URS).
• Handling qualification impact assessments as part of change or deviation process management.
• Collaborating closely and communicating intensively with other departments

Requirements:
• Proficient experience in the qualification and validation of machines and processes
• Several years hands on work experience in qualification in the pharma industry
• Experience with CSV/automation
• Experience with Siemens COMOS, EVAL (ValGenesis) and VIVA

Languages:
• German fluency (C1 / C2 Level)
• English fluency (C1 / C2 Level)

Reference Nr.: 924219FC
Role: Qualification Expert
Industry: Pharma
Work Location: Kaiseraugst, Switzerland
Workload: 100%
Start: ASAP
Duration: 12 month

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.