. An understanding of clean room practice/cGMP and laboratory/GLP environments is required. The qualified candidate must understand the... that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements. Support...
of and experience in Quality Risk Management methods Knowledge of US and European cGMP guidelines, ICH and other international...: Accountability, Accountability, Aseptic Processing, Audit Management, Biological Sciences, cGMP Training, Customer-Focused, Detail...
Summary The Vice President, Principal Consulting is a senior executive responsible for leading the company...'s most strategic consulting engagements, shaping market-facing capabilities, and driving significant revenue growth. This role combines...
. An understanding of clean room practice/cGMP and laboratory/GLP environments is required. The qualified candidate must understand the... that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements. Support...
documentations as required for projects;serve as the subject matter expert during audits and inspections and consulting... on validation and cGMP questions and issues. The ideal candidate will work on extremely complex problems in which analysis...
within a regulated industry framework (e.g., cGMP, FDA). Individual will also need to be proficient in computer system validation... and locking down consulting services for Excel (xls) spreadsheets used in a biotech laboratory Locking down of spreadsheets...
documentation for facilities, utilities, and standard equipment/systems/software Actively consulting clients on regulatory... facilities Strong knowledge of validation principles, cGMP, FDA regulations (21 CFR Part 11, Part 210/211), and industry...
with these learnings. Major Capital Support - Provides technical consulting and leadership, both conceptual and detailed design... Manufacturing Support - Provides technical consulting and leadership to Lilly’s external manufacturing partners. Responsibilities...
for a company leading the way in developing and producing unique, innovative immunotherapies? Do you have a background in cGMP... and knowledge and to ensure compliance with cGMP requirements Routinely monitors, cleans, prepares and operates sophisticated...
and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis... and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications: Bachelor...