- Lilly (Concord, NC)
- …and priorities within the Quality System, including driving enhancements to the change control quality system from a current state to a desired future state. ... world. **Responsibilities** : The Global Process Owner for Change Control , as a leader within the Global Quality...operations, regulatory and other functions to educate on the quality system and proactively ensure compliance of… more
- Insight Global (Raleigh, NC)
- …delivery, application management and change management solutions are managed in compliance with Pharmaceutical and Manufacturing industry regulations and ... guidelines (FDA 21 CFR Part 11, EU Annex 11, GxP, GAMP), ensuring compliance with international pharmaceutical regulations and company policies -Computer Systems… more
- Corning Incorporated (Durham, NC)
- …plant systems support. Develop and improve quality systems, ie, quality records, engineering change control , corrective and preventive actions, and ... quality metrics. **Responsibilities** + Lead improvements in product quality and systems compliance . + Assist with...Control and Training systems at the plant. Ensure compliance with Division Document Control and Training… more
- Novo Nordisk (Durham, NC)
- …& functions in Department + Quality Risk Management + Make decisions on quality & compliance issues with little guidance + Participate in process group ... of standards within the assigned process + Provide coaching to Site regarding quality & compliance related activities + Facilitate sharing of regulatory &… more
- Ingersoll Rand (Lillington, NC)
- …the Pharmaceutical /Medical Device Industry with a primary focus on working in a Quality Control / Engineering capacity. + Experience working in a clean room ... laws, regulations and ordinances. **Job Summary:** The PharmBio business quality engineer actively supports on-site pharmaceutical containment manufacturing… more
- J&J Family of Companies (Raleigh, NC)
- …may reduce the experience required. Demonstrates knowledge of Quality Assurance, Quality Control and Compliance . + Experience in External Manufacturing, ... North Carolina (FDBN) and be responsible for the overall Quality and Compliance oversight of the FDBN...in a regulated environment is required; preferably in a pharmaceutical /Medical device/Biotech manufacturing or quality environment.… more
- Catalent Pharma Solutions (Greenville, NC)
- …advance and model company values and leadership commitments; ensure the highest levels of quality , compliance and integrity are adhered to in all interactions. + ... systems such as deviation management, analytical investigations (OOS), CAPA and change control . + Demonstrated experience leading Quality Assurance teams in… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- … which includes, but is not limited to, the following systems: Document Control , Electronic Quality Management Systems (Investigation, Change Control , CAPA) ... and major market complaints. Operational Excellence: + Handling of QMS documents like Quality Event/ deviation investigation, Change Control , APR etc. + Review… more
- IQVIA (Durham, NC)
- …technology compliance + M&A IT system evaluation, ensures export control compliance + Contributes to sponsor RFIs, enhances operational efficiency, ... processes. **Essential Functions:** + Defining & executing validation strategy to improve quality & compliance , ensures adherence to global regulations (FDA,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …POSITION SUMMARY: The Analytical Quality Assurance (AQA) Specialist will work with the Quality Control team to work side by side on the floor acting as ... testing is performed in accordance with applicable procedures and compliance standards, ensure Data Integrity is maintained at all...Microbiology, or equivalent Experience: 2 - 3 years in Quality Control , or equivalent Knowledge and Skills:… more
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