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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Bachelor of Chemical Engineering
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Specialist Manufacturing, Process Development & Establishment, Introduction of ERP-Systems, Manufacturing Monitoring, Manufacturing Batch Records, Change Control, SOPs, Commissioning, Qualification, Aspetic Filling, GMP, Pharma / Biotech
Key-Facts
Extract from previous activities
Biotechnological Company, Germany
Project Manager / Commissioning Coordinator
Process development within production
Writing of SOPs
Commissioning management for 72 sub-systems and ensuring that deadlines are met and the required quality is maintained
Planning, execution and responsibility of the project phase transition from the commissioning phase to the handover phase for handover to the subsequent operators of the plants
Support of all qualification activities
Pharmaceutical Company, Germany
Interim Manager Operations
Restart of a production plant after a major fire
Complete reorganization of internal processes from order acceptance to delivery of finished products
Production monitoring
Manufacturing batch records
Deviation Management
Project completion of the newly acquired machinery and equipment, including defect-free acceptance, maintenance contracts, work instructions, personnel training and productivity maximization
Further development of the existing product portfolio in terms of cost efficiency, process reliability and individual customer requirements
MPA certification of the products
Chemical Company, Germany
Manager Operations
Change management of an owner-managed production site to an international group member
Process establishment to increase production output and improve quality
Implementation of international group guidelines for production processes, project management, machine guidelines, occupational safety and group reporting
Management of new product introduction, transfer and customer projects
Project management of the introduction of the ERP system Oracle (Keyuser Operations)
Implementation of new production lines such as pesticide filtration and evaporation plants
Raw material, part finished goods and finished goods inventory management
Coordination, execution and implementation of all site qualification activities and process and cleaning validations
Auditing and set-up of international contract and toll manufacturers (contract manufacturing)
Close cooperation with quality relevant departments on technology, method and product transfers
Collaboration in the recertification of cGMP, FSSC, ISO, IFS certificates in the area of responsibility