Summary: We are seeking a talented Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes and systems. You will be responsible for...
Responsibilities: Responsible for the oversight of all data management CRO activities supporting company's clinical programs from database start-up through database lock and CSR/submission. Serves as primary point of contact with the DM ...
Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs act...
Summary : Strong experience holding the responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 5 years of experience in GCP Qual...
Roles & Responsibilities: Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes. Lead PFMEA sessions to identify and mitigate risks. Design and validate test methods to ensure ...
Summary : Seeking an experienced Medical Device Quality Engineer to support the launch of a new product into production. The role focuses on process validation and ensuring compliance with medical device quality and regulatory standards. ...
Roles & Responsibilities: The individual would be part of the Site Quality Organization and will participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance Vaccines and ...
Job Description: The Regulatory Affairs Associate will be responsible for managing, authoring, and compiling Chemistry, Manufacturing, and Control (CMC) sections of regulatory submissions for marketed product variations, including Class II...
Responsibilities: Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. Provide strategic oversight and direction to CRO clinical data m...
Summary: We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualificat...