Job Description: Quality Engineer I supports the development, implementation, and maintenance of quality systems within an aerospace manufacturing environment. This role ensures that products meet internal standards, customer requirements...
Summary : The CSV Specialist will plan, execute, and document validation activities for GxP-regulated computerized systems. This role supports system lifecycle activities, audits, and compliance initiatives while ensuring adherence to FDA...
Job description: Our client is seeking an experienced Regulatory Operations Consultant to support Veeva Vault RIM, with a primary focus on archiving legacy regulatory content and mitigating documentation into Veeva Vault. This role will p...
Job Description: The GCP Quality Assurance Auditor reports to the Director of GCP/PVG Quality Assurance and is responsible for ensuring GxP compliance with regulatory authorities. The role focuses on implementing compliance directives, su...
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: 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...
Roles & Responsibilities: Own end-to-end deviation investigations and effectively collaborate cross-functionally to ensure a thorough, risk-based investigation is conducted for each quality event commensurate with the event classification...
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...
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...
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...