Beschreibung
We are looking for a QA specialist to actively support the manufacturing unit in all GMP aspects.Tasks:
Ensure GMP and regulatory compliance of the manufacturing unit and its suppliers
Review and approve GMP documents and records, e.g. process and cleaning validation, changes, deviations, master batch records etc.
Execute batch disposition of Chemical Intermediate and Drug Substance batches
Support the manufacturing unit in all GMP aspects
Participate in deviation investigation cross functional teams and approve deviation records and associated actions and CAPAs
Support the preparation and follow-up inspections/audits by health authorities, customers and internal teams
Support launch products
Maintenance and adherence to cGMP and SOPs
Author/develop Modules for the Quality Manual and local SOPs
Minimum requirements:
Michael Bailey International is acting as an Employment Business in relation to this vacancy.