The Senior Officer QC (Raw Material) will be responsible for testing and analysis of raw materials to ensure compliance with pharmacopeial standards (USP BP IP) and GMP regulations.
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.
Required Experience:
Senior IC
Velosi became part of the Applus Corporation in 2011, and is now an integral part of the Energy & Industry division of the Applus+ Group of companies. Established in 1983 by Engineers for Engineers, Applus+ has built an outstanding reputation for consistently sourcing and delivering ... View more