Zusammenfassung
About the Role
Strategy & Organizational Development:
- Support internal and external audits
- Create and maintain GOPs and provide standard training
- Implement GOPs
- If needed, create regional / site SOPs & templates
- C&Q related IT system owner for Haiyan Site
Project Engineering & Control:
- Develop Project schedule
- Perform project risk assessment
- Identify technical solutions
- Prepare project quality plan
- Develop project document management and archiving concept
- Perform project reviews (e.g. Technical Quality Review (TQR), constructability, sustainability, HSE)
- Develop project commissioning plan / strategy
- Establish project change management and manage changes
- Develop project execution plan (e.g. C&Q)
- Prepare / execute Project Health & Safety Risk Assessments (Equipment / Process)
- Expedite and manage project vendors / contractors / 3rd parties in project
- Develop test specification / plan for commissioning & qualification in projects
- Perform new equipment FAT / SAT / inspections in project
- Implement and monitor construction contractor safety and inspection plan
- Execute work orders for projects as per method statement
- Perform commissioning activities
- Manage project deficiencies and deviations
- Perform provisional and final project handover
Maintenance & Calibration:
- Plan initial calibrations
- Coordinate maintenance / calibration activities
- Plan resources for maintenance / calibration
- Allocate work for maintenance / calibration to technicians
- Identify spare parts for maintenance and maintain pick-lists
- Establish Master Instrument Inventory (MII) and Master Equipment Inventory (MEI)
- Get permits for maintenance / calibration / projects
- Execute work orders for maintenance / calibration as per method statement / procedure
- Provide front line support for technicians
- Supervise maintenance and calibration works
- Assess quality impact and release after maintenance work
- Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request
- Execute change requests
- Investigate deviations (root cause analysis)
- Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets)
(Re-) Qualification:
- Develop qualification plan
- Perform GMP risk assessments (incl. Sensors SRA)
- Create DQ, IQ and OQ protocols
- Execute DQ, IQ and OQ
- Create DQ, IQ and OQ reports
- Provide technical trouble shooting during PQ and validation
- Develop periodic requalification plan
- Execute periodic requalification plan
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
