Raw Material Testing: Perform physicochemical and instrumental analysis (HPLC GC UV FTIR Titrations) of raw materials and excipients. Compliance & Documentation: Maintain test records COAs and laboratory documentation as per GMP GLP and data integrity guidelines. Sampling & Specifications: Ensure proper sampling handling and release of raw materials as per approved specifications. OOS & Deviation Management: Investigate out-of-specification (OOS) results deviations and laboratory incidents implementing CAPA as required. Audit Readiness: Support regulatory audits (USFDA MHRA WHO EU-GMP) by ensuring QC compliance and preparing required documentation.
Raw Material Testing: Perform physicochemical and instrumental analysis (HPLC GC UV FTIR Titrations) of raw materials and excipients. Compliance & Documentation: Maintain test records COAs and laboratory documentation as per GMP GLP and data integrity guidelines. Sampling & Specifications: Ensure p...
Raw Material Testing: Perform physicochemical and instrumental analysis (HPLC GC UV FTIR Titrations) of raw materials and excipients. Compliance & Documentation: Maintain test records COAs and laboratory documentation as per GMP GLP and data integrity guidelines. Sampling & Specifications: Ensure proper sampling handling and release of raw materials as per approved specifications. OOS & Deviation Management: Investigate out-of-specification (OOS) results deviations and laboratory incidents implementing CAPA as required. Audit Readiness: Support regulatory audits (USFDA MHRA WHO EU-GMP) by ensuring QC compliance and preparing required documentation.