Sr. Specialist Qa

Descripción del Empleo:
Approve process validation protocols and reports for mfg. Processes. Represent Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Own site quality program procedures. Designee for QA manager on local CCRB.
Requisitos:
Bachelor’s degree in Sciences/Engineering and 8 years of directly related experience.
Commissioning & Qualification Process Validation Quality Management of GMP Documents and Batch Related Records QA Operations Oversight (i.e. “on the floor” Quality oversight, troubleshooting and decision making during activities execution) Hands on experience on Parenteral / Biological DP Manufacturing Experience on Drug Product Aseptic Processing.