The Role
Review raw analytical data, worksheets, instrument printouts, test reports and COAs for accuracy and compliance. Verify calculations, chromatograms, integration parameters, and result interpretations. Ensure ALCOA+ and data integrity. Review analytical methods, specifications, and QC-related deviations (OOS/OOT), incident reports, CAPA, and change controls. Ensure scientifically justified root cause, impact assessment, and CAPA effectiveness.
Summary Generated by Built In
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- Review raw analytical data, worksheets, and instrument printouts for accuracy and compliance.
- Review test reports, COAs, and analytical result summaries before release.
- Verify calculations, chromatograms, integration parameters, and result interpretations.
- Ensure adherence to ALCOA+ and data integrity standards. a { text-decoration: none; color: #464feb; } tr th, tr td { border: 1px solid #e6e6e6; } tr th { background-color: #f5f5f5; }
- Review analytical methods for completeness and compliance.
- Review specifications for raw materials, in‑process materials, intermediates, and finished products. a { text-decoration: none; color: #464feb; } tr th, tr td { border: 1px solid #e6e6e6; } tr th { background-color: #f5f5f5; }
- Review QC-related deviations, OOS, OOT, incident reports, CAPA, change controls.
- Ensure root cause, impact assessment, and CAPA effectiveness are scientifically justified
M.Pharm and /or any PG
Skills Required
- Postgraduate degree (M.Pharm or any post-graduate)
- Experience reviewing raw analytical data, worksheets, and instrument printouts
- Experience reviewing test reports, COAs, and analytical result summaries
- Knowledge of ALCOA+ and data integrity standards
- Experience verifying calculations, chromatograms, integration parameters, and result interpretations
- Experience handling QC deviations, OOS, OOT, incident reports, CAPA, and change controls
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The Company
What We Do
DifGen Pharmaceuticals is a US-based global pharmaceutical company specializing in the development and manufacturing of complex, high-barrier-to-entry generic and specialty pharmaceutical products. The company focuses on creating dependable solutions in product development and commercialization to increase accessibility to high-quality medications, thereby leading to the creation of next-generation healthy communities.
