Qualification Engineer
Visualizza: 205
Giorno di aggiornamento: 26-03-2024
Località: Saint-Prex Vaud VD
Categoria: Consiglio di amministrazione Produzione / Funzionamento
Industria: Medical Devices Pharmaceuticals Research
Tipo di lavoro: Full-time
Contenuto del lavoro
Job Title:Qualification EngineerJob Description:
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
- 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
Scadenza: 10-05-2024
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