About The Role:
A major pharmaceutical company is investing into a new aseptic cartridge filling capacity in an existing site. This project includes a high-speed filling line, two formulation skids, two components processor, one dispensing isolator, infrastructure, and utilities modifications.
This role will be expected to develop and execute Engineering documentation for the project. The overall project will be expected cover a duration of 24months.
The project will be implementing in existing building where all utilities supply will have to be modified for the new process equipment’s. Clean and Back utilities will be concerned by modifications. Regarding HVAC systems, existing installation will be modified, and additional installations will be required. Dedicated studies will be performed for modifications required.
- Perform C&Q in accordance with GFD procedures, best practices, specifications, and project planning documents.
- Preparation of documents associated with C&Q activities.
- Preparation and execution of FAT, and SAT protocols
- Review equipment specifications to ensure FAT, SAT and PIM requirements are included, as appropriate.
- Preparation and execution of Qualification protocols (IQ,OQ, PQ)
- Design Qualification (DQ) protocol preparation, execution, and follow-up
- Field Walkdowns of systems as part of transfer of ownership of the system from Construction
- Ensuring safe operation of the system prior to and during start-up functional testing and Qualification phases
- Nonconformity management during project lifecycle
- Summary Report writing
- Organize and review daily tasks/verifications and track the progress of the activities assigned.
- Contractors and/or Vendors coordination
- Interfacing with representatives on project team, Construction, Engineering, Automation, Quality and End Users during the different project phases.
- Collaborate with Automation contractors in support of integrated C&Q/CSV approach.
- Provide weekly status updates to C&Q Formulation Lead
- Review C&Q plans/protocols as related to utilities and HVAC systems.
- Provided monthly update for the C&Q Project Lead