Guides the work efforts of consultants and other team members, and mentors them in all areas of computer system compliance and validation. Develop and implement CSV and Data Integrity processes to ensure compliance with GxP, GAMP, OECD, and applicable regulations in conjunction with the operations counterpart. Responsible for providing input for maintaining the IT Master Inventory of Electronic Systems. Lead CSV projects, provide guidance to the ...
This is a. third-shift. role with hours from 11:00 PM - 7:00 AM, Sunday - Thursday. Perform Line change over, set-up, start-up, including vision system training and data collection. Identify parts needed for repairs using parts manual for specific equipment, and will assemble requisition for supervisor to order parts. Responsible for on-going preventative maintenance of machinery or equipment. Required skills include, but are not limited to, mech...
Job Requirements. Must have a thorough understanding of cGMP and GDP requirements. Must be able to think critically and exercise sound judgment when making critical decisions. Must be able to navigate company quality and/or enterprise systems as needed to perform assigned tasks. Must coordinate closely with shift supervisors across all three shifts. Must be able to generate, read, and interpret metrics and develop visual presentations for group d...
Perform MS&T activities with limited supervision for pharmaceutical products including parenteral and nasal products for all new products from scale-up to commercialization and process improvement beyond commercialization. Continue to grow in understanding the overall generic and new drug development processes, Agency requirements, and CMC strategies. Understand and comply with all the Renaissance safety, environmental and quality practices and p...
