of 10 years experience in aseptic drug product compounding in a biotherapeutics cGMP environment (preferably in process... facility/equipment design Solid understanding of the following : cGMP's for biotherapeutics DP aseptic compounding EHS...
‑art aseptic filling line systems (vial and syringe) within a new cGMP manufacturing facility. Using deep scientific... policies, cGMP requirements, global regulatory standards, and customer specifications. Qualifications Education: Minimum...
, solvent recovery concepts) where they make valuable contributions Ensure API cGMP standards are applied consistently... understanding of reactor systems, solvent handling, and process analytical/controls as applicable Strong understanding of cGMP...
equipment preparation area for a new cGMP drug product manufacturing plant. They will be responsible for leveraging... of the following: cGMP's for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the...
processes, equipment, and systems comply with cGMP, aseptic processing requirements, and global regulatory expectations. Author... experience applying and maintaining cGMP compliance within aseptic DP operations, including participation in regulatory...
calibration, commissioning and consulting solutions. At PCI, calibrations are performed by highly technical, cGMP/GLP-trained...
by providing calibration, commissioning and consulting solutions. At PCI, calibrations are performed by highly technical, cGMP/GLP...
by providing calibration, commissioning and consulting solutions. At PCI, calibrations are performed by highly technical, cGMP/GLP...
, and clinical research industries nationwide by providing calibration, commissioning and consulting solutions. At PCI, calibrations... are performed by highly technical, cGMP/GLP-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA...
, and clinical research industries nationwide by providing calibration, commissioning and consulting solutions. At PCI, calibrations... are performed by highly technical, cGMP/GLP-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA...