- Catalent Pharma Solutions (Greenville, NC)
- …function, able to troubleshoot instrument, method and technique-related issues. + Project management and serve as Analytical representative for internal and external ... and, as required, CMOs. + Author and review analytical procedures, validation documents, portions of regulatory submissions for site pre-commercial and commercial… more
- USAA (Charlotte, NC)
- …development and retention of talent with requisite regulatory issue validation capabilities as well as providing leadership and overseeing performance ... strengths related to complying with policies, standards and procedures. + Reviews validation testing for area of responsibility to ensure that the recommended… more
- Fujifilm (Holly Springs, NC)
- …of operational and inspection readiness goals, leading in both a project and routine operations environment. * Maintains relationships with site-based customers ... * Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software is a plus * Understanding of the following processes… more
- Lilly (Concord, NC)
- …life better for people around the world. **Responsibilities:** During the project phase, the Operations Manager (OM) will support commissioning, qualification, and ... validation of the Device Assembly and Packaging (DAP) areas...Equipment, Systems Start-up + Equipment design, qualification, and process validation . + Manufacturing Execution Systems and electronic batch release.… more
- ThermoFisher Scientific (Greenville, NC)
- …client projects and will collaborate closely with analytical, quality, and project management teams to drive successful process development and commercialization. ... + Prepare batch records, protocols, and reports to support development, validation , and routine commercial production. + Support routine manufacturing and act… more
- ThermoFisher Scientific (Greenville, NC)
- …a focus on robustness and compliance. + Collaborate with quality, operations, validation , and analytical teams to advance development and commercialization. + Apply ... and controlled-release dosage forms. + In-depth knowledge of GMP, process validation , and regulatory requirements. + Strong problem-solving, communication, and … more
- Fujifilm (Holly Springs, NC)
- …accurate maintenance records and documentation * Participates in overseeing validation and qualification activities to ensure compliance with regulatory requirements ... experience in a manufacturing or pharmaceutical environment * Experience with project management and budgeting * Experience with regulatory inspections and audits… more
- Two95 International Inc. (Durham, NC)
- …10-12+ years of pharma industry analytical experience working within analytical development/ validation to support solid oral dosage forms (small molecules), Ph.D. ... with 5-7+ years. + Excellent method development and validation skills and routine analysis on pharmaceutical materials (including potent compounds). + Strong… more
- Deloitte (Raleigh, NC)
- …for the technical direction of client engagements while defining the project strategy, communicating complex concepts to both technical and non-technical audiences, ... + Lead in the research and adoption of industry best practices for validation and deployment of models; support best delivery practices, code review, UAT, unit,… more
- Mallinckrodt Pharmaceuticals (Raleigh, NC)
- …Team in developing and implementing capital projects. Activities include project scoping, operating requirements, process controls, process tolerances, alarm ... rationalization, and validation . + Prepares periodic reports that summarize production rate,...Skills: Competencies: Understanding of GMPs (ICH Q7) and process validation Understanding of Six Sigma and Lean Manufacturing tools… more
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