Summary : The Sr. Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Sr. Quality Manager coordinates or executes activities on multiple complex projects and takes ...
Roles& Responsibilities: Lead the development, execution, and approval of validation master plans, validation plans, IQ/OQ/PQ protocols, and final reports, with emphasis on sterilization, endotoxin control, and microbiology-related proces...
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...
Responsibilities: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities f...
Summary : As a Computer System Validation (CSV) Engineer specializing in the pharmaceutical industry, you will ensure that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation plat...
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...
Roles & Responsibilities: Must have basic knowledge or understanding of Pharmaceutical/Medical Device compliances like 21 CFR Part 11 Compliance, GAMP, GDP etc. Previous work experience in MES implementation using any platform. Must hav...
Job Summary: Responsible for manufacturing and assembling clinical and commercial products. Operates production equipment. Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities. ...
Roles & Responsibilities: Writing and execution of validation protocols and reports (ie. IQ, OQ, PQ, etc.) Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, pro...
Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, pediatric planning, and accelerated procedures, e...