30.12.2025 aktualisiert

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CQV-Consultant / Commissioning&Qualification, Quality Management

Pratteln, Schweiz
Weltweit
Pratteln, Schweiz
Weltweit

Skills

Good Manufacturing PracticesIEC 61508Lean Six SigmaQualitätsmanagementRisikomanagement
  1. 13 years working experience with 8 in GMP environment
  2. Passion to drive and excel
  3. Qualification/Validation Manager/Lead, Quality Management, Safety and Reliability in a GMP-environment
  4. Experience presenting in front of Health Authorities
  5. Certified Auditor & Lean Six Sigma Black Belt
  6. Certified Safety Manager & Specialist - IEC 61508
  7. Technical Problem Solving, Risk Management & Quality Management
  8. Team-Player, precise, detail-focused, reliable and autonomous
  9. English spoken and written

Erfahrung

Berufserfahrungmehr als 10 Jahre
Freelancer seit2020

Sprachen

DeutschMutterspracheEnglischverhandlungssicher

Projekthistorie

C&Q Lead / Manager

Leading & Managing 3 major (100 to 300Mio) and 2 smaller (15 to 20Mio) projects for customer in Valais
Brown Field & Green Field projects in Biologics and Small Molecules environment

  1. Accountable and responsible for delivering safe, in time, in quality C&Q deliverables (BU, CU, HVAC, CR, Process, Support)
  2. Manloading, Hiring and releasing staff, Performance evaluation
  3. Contract initiation and due diligence checks for external vendors
  4. Coordinate all CQV tasks with multiple direct reports and up to 90 indirect reports incl. remote team and field execution team
  5. Manage schedule for C&Q deliverables until handover to end-user, workload distribution, escalation of hold ups and collaboration with site stakeholders to solute schedule constraints
  6. Track, follow up and reporting on CQV tasks
  7. Review & approving of individual C&Q and handover protocols
  8. Support QA and CoE Team with preparation for Authority Inspection
  9. Develope & Release (Project-) Qualification Plan
  10. Verify & Approve Equipment-URS
  11. Coordinate all CQV tasks in generation and execution with a team of 3 plus one external Engineering service provider (EPCM) to adhere to Project schedule
  12. Support development of Schedule (General & Detail plan)
  13. Handling of Non-Conformacies / Deviations using Trackwise and assuring compliance to QM standards
  14. Executing protocols paper-based and also digitally via KNEAT

Commissioning/Qualification Lead

  1. Create Qualification plans (DQ, IQ, OQ, PQ) for new packaging equipment Cartoner, Sleeve-machine)
  2. Coordinate, Release of FAT/SAT-Test plans
  3. Execution of SAT, IQ, OQ, PQ for new Packaging Equipment incl. Deviation management, trouble shooting with supplier
  4. Creation of sampling plans for Process Validation and Process Validation Reports
  5. Qualification of ceramic pumps for filling line (Aseptic area)
  6. Qualification of secondary packaging (Sleeve-foil, leaflet, folding boxes)
  7. Qualification of minor equipment
  8. Qualification (DQ, IQ, OQ, PQ) of process equipment (Packaging, aseptic area)

Plant Engineer

Roche Basel - Solida production
  1. Create, Adapt, Delete Task Lists and Maintenace Plans using SAP PM
  2. Create, Adapt, Delete Inventory stock, BOMs using SAP PM
  3. Optimize inventory stock regarding Equipment Reliability and overall cost
  4. Breakdown-Analysis of Process Equipment
  5. Create, Adapt, Delete GMP-documents of Maintenance department
  6. Reporting of Equipment performance
  7. Ensuring that activities adhere to GMP, HSE procedures/rules
  8. Reviewing and closing of work orders
  9. Defining priorities and assigning tasks
  10. Work closely with process engineering for modification and CAPEX projects

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