FDA VALIDATION AND IT jobs in BOSTON MA, United Kingdom

one like you and that’s why there’s nowhere like RSM. FDA Validation and IT Quality Director The ERP and Automation Risk Consulting practice... introductions and extend other RSM value added services. Experience 12+ years’ experience with FDA, GxP, GMP IT validation...

as well as overall technical and system-based improvement projects. Responsible for oversight and organization of CICL IT infrastructure... coordination with MGB ERIS, IT Security, and Research Compliance. Analyzes relevant data and provides performance reports...

as well as overall technical and system-based improvement projects. Responsible for oversight and organization of CICL IT infrastructure... coordination with MGB ERIS, IT Security, and Research Compliance. Analyzes relevant data and provides performance reports...

Boston Medical Center (BMC) is more than a hospital. It´s a network of support and care that touches the lives... of hundreds of thousands of people in need each year. It is the largest and busiest provider of trauma and emergency services in...

operational efficiency. Make an impact. Build the career you’ve always wanted. Join our team and experience more. What’s in it... mitigation. Ensure operational compliance with FDA, ISO, and any other applicable domestic and international regulations...

. The Flow Manager is accountable for direct oversight of staff to ensure compliance with cGMP, FDA and AABB standards.... Functions as a super-user of donor center IT systems and works the Blood Bank IT team to address issues. Works with mobile drive...

. The Flow Manager is accountable for direct oversight of staff to ensure compliance with cGMP, FDA and AABB standards.... Functions as a super-user of donor center IT systems and works the Blood Bank IT team to address issues. Works with mobile drive...

analysis, perform all aspects of formative and summative validation studies, develop submission content, engage with health... together that satisfy Design History File/Design Control requirements including risk management, verification and validation...

pharma) and from a CRO. If you're from a CRO, you should have a good understanding of what it takes to manage a CRO... documentation including the electronic Diary Specifications CRF, Data Management Plan, CRF Completion Guidelines, Data Validation...

monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities..., our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology... pivotal phase analytical development, including method development, validation, transfer, process and product development...

, PTS, and with partners across the business including Clinical Pharmacology, Clinical Operations, Procurement, R&D and IT... (qualification, validation, etc) requirements needed to support clinical endpoints. Coordinate assigned studies and programs...

Shift Tuesday – Saturday 2:00PM – 10:30PM The Role Provide support for validation, calibration, and preventative... of relevant experience, preferably in cGMP biopharmaceutical, pharmaceutical, medical device, food, or other FDA regulated...

Sunday – Thursday 6:00AM – 2:30PM The Role Provide support for validation, calibration, and preventative maintenance... of relevant experience, preferably in cGMP biopharmaceutical, pharmaceutical, medical device, food, or other FDA regulated...

and development to commercialization, and process /analytical method validation as it relates to unit operations for the manufacture... of product, including lifecycle management and Post-Marketing Commitments. Ensuring that all design activities adhere to FDA...

start-up, commissioning and validation support for a commercial scale spray dryers, secondary dryers, encapsulators... required; Experience working in an FDA regulated operation, preferably in the pharmaceutical/biotechnology area; Knowledge of Good...

technical documents (e.g. Validation Plan, Validation Summary Reports, User Acceptance Testing, etc.) on behalf of the Business... QA and IT teams supporting compliance and system functionality, and internal functions who inform and/or consume data...