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.