Perform line clearance and ensure readiness before batch production.
In-process checks during manufacturing & packaging (e.g. weight variation hardness friability disintegration dissolution leak test etc.).
Monitor critical stages of manufacturing: granulation compression coating filling sterilization filtration.
Verification of batch records log books and online documentation.
Ensure compliance with SOPs GMP and regulatory guidelines (USFDA MHRA WHO EU etc.).
Handle deviations change controls and incident reporting.
Perform environmental monitoring in sterile areas (if applicable).
Participate in self-inspections audits and training programs.
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