- 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 QC microbiology deviations and change...manufacturing groups + Knowledgeable in technical guidance documents from FDA , EMA, PDA, ISPE, ICH, ISO, PIC/S and other… 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
- Novo Nordisk (Bloomington, IN)
- …systems + 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 operation,...and corrective actions as it pertains to automation system validation + Identify and implement improvement opportunities for established… more
- Cardinal Health (Indianapolis, IN)
- … validation , and/or transfer protocols, analytical equipment qualification protocols, or computer system validation test scripts, as needed. + Performs ... of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred. + Has experience in authoring… more
- Novo Nordisk (Bloomington, IN)
- …assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems ... oversight of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of the… more
- Lilly (Indianapolis, IN)
- …delivery of key site strategic initiatives. + Compliance Knowledge: Possess knowledge of computer system validation and related practices, including GMP, 21 CFR ... implementation, following quality procedures (ie, Change Control), create and execute validation requirements, and support manufacturing systems. The role will also… more
- Novo Nordisk (Bloomington, IN)
- …+ Process Leadership and Strategy: + Lead the design, development, and validation of aseptic manufacturing processes, ensuring adherence to the highest quality ... documentation, including Standard Operating Procedures (SOPs), batch records, and validation reports, in compliance with GMP standards. + Ensure compliance… more
- Sumitomo Pharma (Indianapolis, IN)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- Novo Nordisk (Bloomington, IN)
- …assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems ... oversight of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of the… more
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