or more years MSAT/Technical or qualification experience in the injection pharmaceutical industry, MNC Bio-pharma preferred People... colleagues, providing guidance in mastering complex qualification workflows, troubleshooting technical challenges, and developing...
to drive operational excellence. Collaborate with MSAT leadership to align qualification and validation strategies with site... in mastering complex Q&V workflows, troubleshooting technical challenges, and developing skills in MSAT operations. Technical 技术...
or more years process and/or cleaning validation experience, 8 or more years MSAT/Technical or qualification and validation... skills in MSAT operations. Technical Engineering Project Support and Site Start Up Readiness: Participate in the design...
related to the SUT, thereby contributing to project delivery. Provide technical and engineering support for MSAT operations... material specifications and master data, including bill of materials (BOM), to support seamless MSAT operations and supply...
and sustained operational excellence. The MSAT F&F Lead/Subject Matter Expert (SME) is a pivotal technical role, designed... into overall facility workflows. Collaborate with MSAT leadership to align process engineering strategies with site and global...
: Provide technical expertise during facility qualification, cleanroom validation, and sterilization process validation...), cleanroom qualification, filtration processes, and aseptic processing controls. Optimize and implement comprehensive...
&E, MSAT, Manufacturing and C&Q team, Acts as subject matter expert in projects for qualification related issues... Roles & Responsibilities / Accountabilities主要职责/责任 Quality and Technical Guidance Oversee qualification & validation...
Readiness project by acting as a coordinator to align the work of Quality, Engineering, MM, MSAT, and other departments. Ensure.... Qualification and Experience Education/Qualifications Bachelor’s degree or higher in Engineering, Pharmaceuticals, Chemistry...
Integrity and validation activities for the project, including but not limited to design, qualification of facilities, critical... in project work streams, ensuring proper execution of design/qualification/validation strategies as well as providing support...
&E, MSAT, manufacturing, and QC teams to address quality issues. Qualification and Experience 能力与经验 Education..., GAMP 5 and applicable regulations in Dragon project phase in collaboration with Project, F&E, MSAT, Manufacturing and C&Q...
facility design, qualification, manufacturing readiness and start-up—and oversee daily operations to ensure long-term success... i.e. training and personnel qualification, documents control, MES and Aspire operation, coordination of Change/Deviation/CAPA, risk...
and Technical Guidance Oversee qualification & validation activities according to the Roche Standards and Good Practices, ensure... regulations in Dragon project phase in collaboration with Project, F&E, MSAT, Manufacturing and C&Q team, Acts as subject matter...
facility design, qualification, manufacturing readiness and start-up—and oversee daily operations to ensure long-term success... including facility design, qualification and manufacturing readiness and start up. The role is key interface with the QA, F...
.Collaboration with above-site functions, and not limited to MKG, MM MSAT, F&E and internal Quality functions. Act as the primary...: Managing the qualification, validation, and ongoing maintenance of the facility and its utilities. Provide regular reports...
facility design, qualification, manufacturing readiness and start-up—and oversee daily operations to ensure long-term success... Leadership Commitments. Play a critical part in strategic project realization including warehouse design, qualification...