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CQ Manager
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Design, Client, Library
Projektbeschreibung
Our global pharmaceutical client is searching for a C&Q Manager to support them on the fit out of a new biologics fill-finish facility.
Reporting to the Project Director, the Commissioning and Qualifications Leader will be responsible for the entire Commissioning and Qualification (C&Q) program from the design stages to completion of qualification.
LOCATION: Scandinavia
DURATION: 2 year project
RATE:Euros all-inclusive daily rate
RESPONSIBILITIES WILL INCLUDE:
- Define strategy for C testing; facility start-up; documentation and regulatory compliance.
- Definition of manufacturing systems including: strategy for design phases; testing strategy and lists; sequence for startup.
- Develop the project C&Q master plan, identify task lists and project timelines in line with the project objectives and goals. Ensure compliance to client and regulatory best practice.
- Lead the C&Q cost, resource and schedule planning and control process.
- Interface with the other project teams to develop the overall C&Q phase project plan and schedule which includes risk assessment, design review/DQ, test Matrix, FAT, SAT/commissioning, installation, operational and performance qualification for all systems.
- Lead the C&Q team (technical writers, commissioning engineers, interfaces to calibration and system owners) and manage day-to-day project C&Q activities.
- Responsible for project C&Q documentation development and management, and quality of the documentation library.
- Manage and close major deficiencies (punch list and exceptions list) in timely manner.
REQUIREMENTS:
- Experience as the C&Q manager/responsible of a startup construction project in the (bio)pharmaceutical industry is essential.
- Experience with fill-finish facilities.
- Experience with current C&Q methods and industry best practice.
- Excellent problem solving and troubleshooting abilities.
- Ability to work in a fast paced environment.
- Experience with working in project environment (Euros >200 million).
- Must be able to establish strong working relationships with team members and other stakeholders.
- Strong people management skills. Must be able to lead a team in the execution of C&Q activities.
Reporting to the Project Director, the Commissioning and Qualifications Leader will be responsible for the entire Commissioning and Qualification (C&Q) program from the design stages to completion of qualification.
LOCATION: Scandinavia
DURATION: 2 year project
RATE:Euros all-inclusive daily rate
RESPONSIBILITIES WILL INCLUDE:
- Define strategy for C testing; facility start-up; documentation and regulatory compliance.
- Definition of manufacturing systems including: strategy for design phases; testing strategy and lists; sequence for startup.
- Develop the project C&Q master plan, identify task lists and project timelines in line with the project objectives and goals. Ensure compliance to client and regulatory best practice.
- Lead the C&Q cost, resource and schedule planning and control process.
- Interface with the other project teams to develop the overall C&Q phase project plan and schedule which includes risk assessment, design review/DQ, test Matrix, FAT, SAT/commissioning, installation, operational and performance qualification for all systems.
- Lead the C&Q team (technical writers, commissioning engineers, interfaces to calibration and system owners) and manage day-to-day project C&Q activities.
- Responsible for project C&Q documentation development and management, and quality of the documentation library.
- Manage and close major deficiencies (punch list and exceptions list) in timely manner.
REQUIREMENTS:
- Experience as the C&Q manager/responsible of a startup construction project in the (bio)pharmaceutical industry is essential.
- Experience with fill-finish facilities.
- Experience with current C&Q methods and industry best practice.
- Excellent problem solving and troubleshooting abilities.
- Ability to work in a fast paced environment.
- Experience with working in project environment (Euros >200 million).
- Must be able to establish strong working relationships with team members and other stakeholders.
- Strong people management skills. Must be able to lead a team in the execution of C&Q activities.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Medien/Design