Job Summary: The Data Integrity Specialist is responsible for implementing and maintaining data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+principles and regulatory standards such as 21 CFR P...
Roles & Responsibilities: Right now, the CSV team is focused on UATs, periodic review, test scripts and change controls for their Medidata CTMS and IT ServiceNow Infrastructure projects. The focus is to have CSV support the ongoing CTMS....
Responsibilities: This role involves reading and interpreting wiring diagrams, as well as troubleshooting electrical systems on vehicles. The position requires custom designing for client orders, which may vary from straightforward to co...
Responsibilities: Lead end-to-end program strategy, planning, and execution. Manage client relationships and drive business development. Ensure operational excellence and financial oversight. Mentor and manage cross-functional engineer...
Job Description: specializing in comprehensive CQV (Commissioning, Qualification, and Validation) and engineering solutions tailored exclusively for the dynamic life science industry. We provide a full spectrum of services, including faci...
Roles & Responsibilities: 5+years experience. US Project management experience. Preferable with experiences on Medical devices: Operations, Manufacturing, Supply chain experiences (diverse profiles to be chosen from). Ideal candi...
Job Description: Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+principles and regulatory standards (21 CFR Part 11, Annex 11). Review audit trails, monitor user acces...
Responsibilities: 1. Testing and Validation: Plan and conduct functional tests and performance evaluations on hardware prototypes. Identify and troubleshoot issues related to hardware functionality and compatibility. Collaborate with so...
Responsibilities: Design, budget, implement, and optimize new and existing manufacturing processes to maintain equipment and systems for optimal performance and compliance. Analyze production yields and workflows to identify bottlenecks,...
Responsibilities: Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CR...