Responsibilities: He/she is expected to have the potential to be the analytics lead for the assigned therapeutic area (TA) to mitigate, resolve and triage certain issues and reduce the touch point needed from the study lead. Responsibili...
Responsibilities: Performs routine production functions including filling, utility operations, packing, packaging, assembling, labeling and inspecting under general supervision. Maintains accurate records and logs in accordance with FDA ...
Roles & Responsibilities: Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. Mentor QA personnel, including organizing and prioritizing daily tasks, and performing t...
Responsibilities: Supporting and Validating Regulatory systems like REMS RIMS. Computer System Validation of Regulatory systems like Regulatory Information Management System, REMS, Publishing, eCTD systems used in pharmaceutical industr...
Responsibilities: We are seeking a Senior Quality Engineer with a strong background in IV bag or IV solutions manufacturing to join our healthcare manufacturing team. The ideal candidate will have experience in a regulated manufacturing e...
Responsibilities: Strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions. The ability to lead and/or support multiple projects simultan...
engineering, Life Sciences, or a related field. 5+ years of experience as a Validation Engineer in the pharmaceutical...
Responsibilities: Lead the supplier qualification process by assessing manufacturing/technology capabilities. Conduct comprehensive gap assessments at target suppliers to identify areas for improvement and create individual supplier dev...
Responsibilities: CSV Deliverables and Activities for the Lab systems at the KOP Facility. Customization of Validation Plan (VP), Requirements Specification (RS), Functional Risk Assessment (FRA), Configuration Specification (CS), Instal...
Responsibilities: Master's degree in Epidemiology, Biostatistics, Computer Science, or other subject with high statistical content. Hands on CDISC/SDTM/ADaM experience. Training or experience using the OMOP common data model. Traini...