Job
Description
Job Responsibility: 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 protocole, conduct the test in the laboratory with the protocol and finalise 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) 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. Skillsets Required: Advanced degree in chemistry, biology, chemical engineering or similar field of study. Experience: at least 1-5 years of experience in pharmaceutical or biopharmaceutical MSAT or a related field. A scientific and technological know-how related to Single Use validation and vaccines manufacturing is an additional asset. Project management skills and Validation technical skills Knowledge and understanding of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Hands on mentality/approach and ability to work in the laboratory. Good knowledge of GSK organization and GSK governance Flexibility to face rapidly changing environment Ability to work in a matrix international organization. Proficiency in writing DSR, FMEA, URS, DQ, VMP, IOQ, VSR, Commissioning protocole, extractable protocols, biocompatibility reports, and leachable risk assessments and PES calculation. Skills to report GSK internally but also with partners externally. Social skills to foster teamwork of people belonging to different organizations / departments / sites/external partners. Excellent communication and negotiation skills. Written and oral fluency in English. Scope: MSAT, or Manufacturing Science and Technology, is a critical function within a pharmaceutical and biopharmaceutical manufacturing organization in general. The GSK MSAT team is responsible for ensuring that products are produced safely, efficiently, and to the highest quality standards. Here are some key activities carried out by the MSAT team: o Process Optimization and Troubleshooting. o Technology Transfer. o Process Validation. o Continuous Improvement. o Technical Support. o Regulatory Compliance. o Data Analysis and Reporting. o Training and Development.
