Your mission:
The Qualification Engineer will manage qualification processes for equipment, utilities, HVAC, PLCs and software systems of our Manufacturing Site.
Main responsibilities:
Define, implement and maintain the qualification system in line with cGMPs, 21 CFR Part 11 and GAMP5. This include equipment, utilities, HVAC, PLCs and software qualification
Apply and implement qualification SOP, related Corporate and ICH guidelines
Ensure qualification status for all GxPs systems
Propose and establish qualification strategy based on risk assessment for new or modified system
Write, related qualification protocols and reports, coordinate and execute qualification
Participate in assessment and execution of Change Control, Deviation and CAPA
Timely follow-up of deviations, CAPAs and CCs in collaboration with the production and other departments
Active participation during Inspection and Customers Audits (incl. preparation)
Participate and propose improvement to SOP qualification review with QA qualification responsible
Required Experience & Competences:
University degree in relevant scientific/technical discipline
At least 5 years experience in qualification in the pharmaceutical industry
Strong understanding of cGMPs
Good knowledge in Regulatory requirements
Good knowledge of manufacturing and packaging operations
Autonomy in the daily business
Strong experience in Pharmaceutical field
Good verbal communication and communication skills (incl. English)
Able to make quality decision on time