08.07.2025 aktualisiert
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Senior Commissioning, Qualification, and Validation Consultant
Basel (CH), Schweiz
Weltweit
M.Sc. PharmaingenieurwesenSkills
QualificationCommissioningQualifizierungValidierungMedizintechnikCQVCSV21 CFR Part 11GAMP5GMP Annex 11
Qualifizierung, Validierung, Commissioning, KNEAT, DALUX, UNIFIER, COMOS, DMS, MS Office, MS Outlook, SAP, LifeDoc, Basics, MS Excel, MS Word, MasterControl, Marzipan, KREDIS, MS PowerPoint, IBM Lotus, PowerPoint, FTIR, Internet, Master Control, Microsoft Outlook, Programmierung in der Sprache R, IBM Notes, Microsoft Excel, Microsoft Powerpoint, Microsoft Word, CSV, GAMP 5, 21 CFR part 11
Sprachen
DeutschverhandlungssicherEnglischverhandlungssicherFranzösischMuttersprache
Projekthistorie
Project Background:
Hands-on commissioning and qualification of a fully automated GMP logistics center with a storage capacity of approximately 60,000 m³, to be completed within 12 weeks.
Performed activities:
‒ Coordination: Management of the commissioning process in collaboration with divers supplier.
‒ Activity Tracking: Monitoring of progress, identification and resolving bottlenecks.
‒ Commissioning: Conduction and documentation of:
▪ Design Qualification (DQ) including Architecture plan review.
▪ Installation verification
▪ System Startup
▪ Operational function testing.
‒ Qualification:
▪ Dq, IQ, OQ, PQ
‒ System addressed:
▪ 16 x cooling units.
▪ 4 x cooling rooms (each 10,000 m³)
▪ HVAC system.
Hands-on commissioning and qualification of a fully automated GMP logistics center with a storage capacity of approximately 60,000 m³, to be completed within 12 weeks.
Performed activities:
‒ Coordination: Management of the commissioning process in collaboration with divers supplier.
‒ Activity Tracking: Monitoring of progress, identification and resolving bottlenecks.
‒ Commissioning: Conduction and documentation of:
▪ Design Qualification (DQ) including Architecture plan review.
▪ Installation verification
▪ System Startup
▪ Operational function testing.
‒ Qualification:
▪ Dq, IQ, OQ, PQ
‒ System addressed:
▪ 16 x cooling units.
▪ 4 x cooling rooms (each 10,000 m³)
▪ HVAC system.
Performed activities:
- Creation of the validation documentation regarding:
- the modifications of a Sterile Filling Line in a Restricted Access Barrier System (RABS) according to Annex 1 requirements.
- The modifications of a Clean Room class B
- Requalification of a semi-automatic visual inspection system Seidenader after a software update as well as CSV Part
- Document created: URS, RA, FMEA, DQ, IQ, OQ and PQ
Performed activities:
Tools used: TrackWise, DMS, SAP, MS Office, MS Outlook, MS Excel
- Support in Annex 1 Implementation at the Lonza site Visp.
- QA Support in approval of Qualification plan
- Processing of Supplier qualification
- QA Data control
Tools used: TrackWise, DMS, SAP, MS Office, MS Outlook, MS Excel