- Novo Nordisk (Bloomington, IN)
- …Functions + Proactively and effectively partner with the facility commissioning/ validation team, including operational protocol development, to implement compliance ... with FDA GMP requirements + Draft SOPs for building and...future capital projects + Apply and enhance existing automation validation programs for the validation of new… more
- Novo Nordisk (Bloomington, IN)
- …team + Collaborate significantly with cross functional groups including Validation , Quality Control, Manufacturing, Process Development, and Facilities + Manage ... integration and CSV (Automation Only) + Apply and enhance existing automation validation methods and templates for the qualification of new and existing production… more
- Abbott (Westfield, IN)
- …conduct training of company personnel for the divisional software development and validation program. + Work with Design and Manufacturing Engineering in the ... completion of system/software requirements and other verification and validation processes. + Create and execute or direct software validation protocols… more
- Lilly (Indianapolis, IN)
- …share best practices, and drive consistency. + Collaborate with system owners, validation leads, and global and site quality representatives to ensure readiness is ... years of experience in quality assurance, regulatory compliance, or IT systems validation in the pharmaceutical or life sciences industry. + Proven experience… more
- Cardinal Health (Indianapolis, IN)
- …6+ years of relevant work experience with 21 CFR 210, 211 in the FDA regulated industry preferred (Pharmaceutical or Medical Device). + Must have experience with ... equipment qualification, software validation , test method validation , and/or process validation preferred. + Has experience in authoring a variety of… more
- Cook Medical (Bloomington, IN)
- …with data engineers . + Interface with internal and third-party audits, including FDA and Notified Bodies . + Adhere to regulatory requirements ( FDA ... statistical projects including process optimization , reliability testing , and method validation + Strong knowledge of medical device regulations (ISO 13485, 21 CFR… more
- Cook Medical (Bloomington, IN)
- …devices including IEC Usability standards, AAMI Human Factors standards and FDA Human Factors Guidance* Author design control documentation like Usability ... of concept selection/refinement, use-related risk identification and formal usability validation with intended users. * Ability to progress work independently… more
- Lilly (Indianapolis, IN)
- …Define and execute the company's DSCSA compliance roadmap, aligning with FDA requirements and corporate quality objectives. + Enterprise Compliance Oversight: Lead ... Regulatory Intelligence & Risk Management: Monitor evolving DSCSA regulations and FDA guidance; assess compliance risks and develop mitigation strategies. +… more
- Novo Nordisk (Bloomington, IN)
- …Essential Functions + Perform or leading risk assessments + Execute continued process validation and annual product review reports + Support tech transfers of new ... products + Support and review process and engineering validation work + Investigate deviations + Speak with clients,...pharmaceutical products + Knowledgeable in technical guidance documents from FDA , EMA, PDA, ISPE, ICH, ISO, PIC/S and other… more
- Novo Nordisk (Bloomington, IN)
- …equipment + Proactively and effectively partner with the facility commissioning/ validation team, including operational protocol development, to implement compliance ... with FDA GMP requirements + Identify improvements and efficiencies of...and corrective actions as it pertains to automation system validation + Identify and implement improvement opportunities for established… more