QA Specialist/QA Manager - Switzerland

Europe / Mainland  /  Commissioning & Qualification  /  Full Time


CAI are hiring for experienced QA Specialist/Manager within their EMEA Operations. This role will be based in Switzerland. We have an attractive position for an experienced professional with expertise in Commissioning and Qualification (C&Q) of manufacturing facilities.
As QA Manager, you will be part of the QA department and be responsible for the quality oversight of C&Q start-up of a new biomanufacturing unit. You will ensure that all processes for facility, equipment, utilities and systems qualification/validation comply with cGMP requirements and internal/external quality standards over the entire life cycle.
 
The role involves, but is not limited to:
·       Owns all quality related responsibilities for the commissioning and qualification activities of dedicated facilities, equipment, utilities and systems related to the GMP manufacturing of biologics.
·       Representative of QA in the project organization in regard to qualification / validation of facilities, utilities, equipment and systems (incl. computerized systems)
·       Support the transfer from the project into production phase and support the handover of the facility to Operation / QA Operation
·       Reviews and releases Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports, etc.)
·       Representative of QA Qualification during FATs
·       Performs assessments and approvals of technical changes requests
·       Supports and approves quality risk analysis
·       Review & approve deviations reports
 
Qualification and Skills required
·       Bachelor, master’s degree or PhD in biotechnology, chemistry, life science or related field
·       5+ years of experience in the GMP regulated pharmaceutical industry; preferably in a role within the Quality Unit, 3+ years of experience related to Commissioning and Qualification (C&Q) of facilities, utilities, equipment and systems (incl. computerized systems)
·       Fluency in German is essential
 
 
If you are interested and qualified for this position, please apply.
 
 

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CAI BENEFITS

(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • No Layoffs in Company History
  • Other Benefits Depending on Country