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Commissioning & Qualification Manager (Pharmaceutical)

Location:
Switzerland
Salary:
Negotiable
Job Type:
Contract
Date Posted:
27 days ago
Expiry Date:
23/03/2025
Job Ref:
BBBH118901_1740150506
Start Date:
21/02/2025
Contact:
Elvina Hasani
Contact Email:
elvina.hasani@earthstreamglobal.com
Specialism:
Industrial

Responsible to/for:
*
Develop Level 2 and 3 C&Q (Commissioning & Qualification) Schedule
*
Execution Readiness
*
Document Preparation management and coordination
*
C&Q execution management and coordination
*
Resource management including C&Q Doc Prep and C&Q Exec
*
Oversight of FATs (Factory Acceptance Tests) and SATs (Site Acceptance Tests)
*
Execution of onsite C&Q test cases
*
Maintain C&Q input to level 4 schedule and cost report
*
Coordinate with Ops regarding PQ (Performance Qualification) and engineering runs
*
Adherence to Lonza safety, compliance and quality procedures
*
Progress tracking and monthly report
*
System CFR (Commissioning Final Report) / QFR (Qualification Final Report)
*
Complete System Handover
*
Technical support for Clean Utilities PQ 1 and EM (Environmental Monitoring) PQ 1
*
C&Q Close Out (QFR)
*
Participation as SME during Authority Inspection and audits
*
Control Training status of C&Q team
Requirements:
*
Minimum 10 years of experience in C&Q Management
*
Similar previous positions in a growth project environment (>50mCHF) is mandatory
*
Proficiency in Small Molecules is mandatory
*
API Experience required
*
English and German are Mandatory
*
Presence on site mandatory (at least 4 days/week during the design phase, full time on site during the execution phase)

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Elvina Hasani

Elvina Hasani

Specialisms: Industrial
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