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 ...
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. Required skills include, but are not limited to, mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines. Maintain, repair and troubleshoot electronics on all producti...
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 functions with limited supervision, such as process development, scale-up, technology transfer, commercialization, and product lifecycle advancements. This individual will ensure he/she is trained in areas related to quality by design, scale-up, technology transfer, manufacturing scale-up, and process improvement. Provide technical knowledge, influence, and thorough planning to drive for timely and appropriate results with limited su...
