Roles & Responsibilities. Experience in validating the Computerized System / Analytical Instrument. Extensive validation experience in 21 CFR Part 11. Good understanding of GxP standards. Good Knowledge in Data Integrity Well acquainted with all the phases of Validation Life Cycle (VLC). Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications), QRA. Extensive experience in creating, r...
Roles & Responsibilities. Experience in validating the Computerized System / Analytical Instrument. Extensive validation experience in 21 CFR Part 11. Good understanding of GxP standards. Good Knowledge in Data Integrity Well acquainted with all the phases of Validation Life Cycle (VLC). Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications), QRA. Extensive experience in creating, r...
Roles & Responsibilities. Experience in validating the Computerized System / Analytical Instrument. Extensive validation experience in 21 CFR Part 11. Good understanding of GxP standards. Good Knowledge in Data Integrity Well acquainted with all the phases of Validation Life Cycle (VLC). Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications), QRA. Extensive experience in creating, r...
Responsibilities. To support our expansion efforts, we are looking to add to our team a person that is experienced in clinical abstraction and large project operations. The role will require wearing many hats and Tempus is looking for an individual that is able to coordinate, grow and maintain the abstraction effort, ensuring abstraction processes are run efficiently and data is captured at the highest quality level while meeting project expectat...
Responsibilities. Utilize SAS to generate and validate tables, listings, and figures (TLF) based on SAP. Use major statistical programming language to perform data analysis for various needs. Provide statistical analysis support for post approval studies. Evaluate and ensure CDISC compliance of study tabulation and analysis data files. Write specifications and statistical programs to generate analysis datasets and outputs. Perform data analysis t...
Responsibilities. Prepare drug listings and lot distribution reports for biologics. Compile documentation and send certificate of pharmaceutical product requests to the FDA. Manage notarizations and legalization / apostille of regulatory documents. Assist with documentation and signature preparation for license renewals and establishment registration. Requirements. Bachelor's degree in a relevant scientific field or equivalent experience in a GMP...
Job Description. Job Description. Roles & Responsibilities. 8-10 Years of Overall IT Experience. Review computerized systems validation documents such as : Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre / Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the int...
