Sr Specialist - MSAT
Sr Specialist - MSAT
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Job Description
Manage the following tasks:
Prepare and manage all the meetings and documents related to the project (agenda minutes Team Site TC .
Ability to develop solution by creating mockups in the laboratory.
Create commissioning protocoled in order to perform testing to confirm the design in regard to early requirements
Act as a validation expert on SUS by:
Creating Design Summary Reports (DSR) based on the feedback of the users
Conducting Failure Mode and Effect Analysis (FMEA) by organizing workshop with the different users in order to capture and evaluate the risks linked to the items to be validated and the usage in the production(s) area. Update the FMEA to V2 at the end of the qualification
Based on the UR Tool and the FMEA Developing the User Requirement Specifications (URS)
Create Coordinating and manage the electronic Change Control (eCC)
Based on the URS and the documentation received by the supplier executing Design Qualification (DQ).
According to the requirements that are still not met during the DQ develop a Validation Master Plans (VMP) in order to meet all the requirements of the URS.
According to the validation strategy developed in the VMP write the IOQ protocoled conduct the test in the laboratory with the protocol and finalized the report based on the testing in the laboratory. Ability to manage incidents that may occur during the laboratory testing.
Compiling and summarize the validation evidence in the Validation Summary Reports (VSR)
Conducting Chemical Compatibility Risk Assessments (CRA) based on data from the supplier
Performing Leachable Risk Assessments (LRA) covering extractible approaches
Calculate Patient Exposure Scenarios (PES) based on the raw data from the supplier
Conducting risk assessments and writing technical rationales.
Ability to conduct BCT testing for shipping validation (in coordination with external lab)
Ability to construct comprehensive training package on specific new technology
Manage the PO process acquiring components from manufacturers.
Ensure progress of the project in alignment with the implementation/PPQ timeline
Anticipate RA impacts and documentation needs with the regulatory
Shipping of components from manufacturers to external laboratories ensuring full GMP traceability and completing the necessary GMP sending checklist.
Provide weekly reporting on progress status performances and issues to VTT manager
Create and manage the appropriate master data linked to the creation of the new items.
Ability to interact and manage suppliers in the frame of tenders for new business allocation.
Review more junior staff document in order to insure their alignment as per technical and quality requirement.
Remote Work :
No
Employment Type
Full Time
