- Novo Nordisk (Bloomington, IN)
- …implementation of improvements + Ownership of Corrective Actions, Change Management, GMP document revision, review and approval + Participate and conduct continuous ... understand decimals) + Required to read, understand, and follow GMP documents + Has basic knowledge of the principles...complex with high quality + Knowledge of cGMP, ICH, FDA , EMA regulations or guidelines + Intermediate understanding of… more
- Novo Nordisk (Bloomington, IN)
- …employees and manages work load for operational area . Reviews and approves GMP documentations while ensuring safety and GMP quality compliance . Supports ... - 4 years relevant experience preferred . Leadership Experience Required . GMP experience preferred . Technical Requirements o Excellent written and verbal… more
- Novo Nordisk (Bloomington, IN)
- …Associate Engineers and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry organizations + Participate ... novel processes + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, and other industry organizations +...+ 0-1 years of relevant leadership experience + 1-year GMP or other regulated industry experience, required Must be… more
- Lilly (Indianapolis, IN)
- …Manufacturing Logistics Quality Assurance, is a Quality professional with expertise in GMP quality assurance and DSCSA compliance. The Sr. Director ensures that ... Define and execute the company's DSCSA compliance roadmap, aligning with FDA requirements and corporate quality objectives. + Enterprise Compliance Oversight: Lead… more
- Bristol Myers Squibb (Indianapolis, IN)
- …internal and external audits to ensure compliance with applicable GxP regulations ( GMP , GLP, GCP), internal procedures, and industry standards. This role supports ... the audit program. + Evaluate compliance with applicable regulatory requirements (eg, FDA , EMA, ICH), internal SOPs, and quality agreements. + Document audit… more
- Bristol Myers Squibb (Indianapolis, IN)
- …related discipline preferred .3-5 years of quality assurance experience . Pharmaceutical and GMP experience preferred. . Experience working with FDA or other ... the quality program to be ready for clinical development and GMP commercial operations. Additional responsibilities may include providing support for corporate… more
- Novo Nordisk (Bloomington, IN)
- …Product - Secondary + Perform Manufacturing review of all types of GMP Documentation including Master Batch Records, Engineering Studies, Logbooks, Forms, etc. to ... required + 5 years pharmaceutical and/or manufacturing experience required + 5 years GMP experience + Technical Requirements + Proficient in Excel, Word, and other… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (New Castle, IN)
- …Production organization while maintaining positive employee relations + Interface with FDA inspection personnel + Must thoroughly understand and ensures that ... employees adhere to company policies and work rules regarding SQF, HACCP, GMP and SOP + Conducts disciplinary actions of supervisory/administrative personnel in… more
- J&J Family of Companies (Warsaw, IN)
- …in a GMP and/or ISO regulated industry and experience with FDA regulated environment. + Supporting a production environment. + Process Validation expertise. ... + Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, GxP, and other applicable regulatory requirements +… more
- Novo Nordisk (Bloomington, IN)
- …Associate Engineers and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry organizations + Lead ... and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry...+ 8+ years of Validation experience + 4 years GMP or regulated industry experience, required + Must be… more