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