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.
Required Experience:
Senior IC
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...
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.
Required Experience:
Senior IC
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