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Research And Development Quality Manager
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- R&D Quality Manager of is responsible for implementing and maintaining a balanced, proactive, and phase appropriate approach to New Product Development, Introduction & Launches (NPD, NPI & NPL), GCP Quality Assurance and associated Technology Transfers from R&D or Customers to commercial settings.
- Reporting to the CQO, the R&D Quality Manager will be a core member of the QC & QA team and responsible for the oversight of the QMS and the implementation, management, ongoing support, and review of FS’s internal GXP validated systems.
- New Product Development, Introduction & Launches (NPD, NPI & NPL), GCP Quality Assurance and associated Technology Transfers, Technical Risk Assessments (TRA), Process Control Strategies etc., raw material and components onboarding, from R&D or Customers to commercial settings.
- Oversee NPD, NPI, NPL stage-gate Process, GCP Quality investigations in collaboration with cross functional department owners
- Oversee Quality activities related to FDA and ROW regulations and Customers across therapeutic areas and provide NPD, NPI, NPL and GCP guidance for all phases of drug development
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