IT System Support Manager California
2/3/2016 4:55 PM

The System Support Manager will be primarily responsible for San Carlos Site Infrastructure Management with a secondary focus on site Information Governance & Management (IGM).This role will support 24x7 GxP and non-GxP operations in two buildings. This person will support both PharmOps and TRD associates and be required to communicate effectively across various Novartis functions and with externa  ...View Job
Validation Lead California-Silicon Valley/Peninsula
2/3/2016 4:49 PM

Executing and managing process validation activities, primary packaging validation activities, cleaning validation activities and complex revalidation activities strategies to meet cGMP requirements on time and quality to ensure that programs are compliant with inspection agencies’ requirements and related SOPs. Validation Master Plan • Lead writing and maintaining Validation Master Plan for  ...View Job
Project Engineer California
2/3/2016 4:48 PM

Supporting the project engineering team with construction and safety supervision on all engineering projects, ensuring all applicable Novartis policies, guidelines, and procedures are followed in the compliant execution of construction and start-up activities. Plans and coordinates assigned project work in support of the assigned project manag-er(s)/engineer(s). Monitors work for compliance to app  ...View Job
Regulatory Compliance Facilitator California-Silicon Valley/Peninsula
2/3/2016 4:48 PM

Manage key Compliance Quality Systems (60% daily duties). and facilitate all on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements (40% daily dut  ...View Job
Process Expert California-Silicon Valley/Peninsula
2/3/2016 4:47 PM

Supports the PU in all process-specific issues, drives continuous process improvement for quality and quantity and ensures GMP requirements are met and guidelines and SOPs are followed. • Provide continuous supply of high quality products that meet technical specifications, cGMP, regulatory policies and procedures. • Root cause analysis and investigation for deviations and complaints (extern  ...View Job
Device Expert California-Silicon Valley/Peninsula
2/3/2016 4:46 PM

The Device Expert is responsible for the device and its documentation after transfer from TRD to TechOps throughout the whole Life Cycle until pruning of the device. This includes the management of changes, deviations and suppliers as well as ensuring all post launch activities are conducted according to regulations. As the receiver of assigned devices and the related Design History file/Design Do  ...View Job