HospiraQuality Investigator
Sep. 2015 - Sep. 2017Vishakhapatnam Area, India-Conduct and oversee investigations for terminally sterilized products
-Investigation areas of focus: Engineering, Chemistry and Microbiology laboratories, equipment and calibration, procedural gaps, validation failures, method transfer, out of specification Phase I (lab) and Phase II (manufacturing)
-CA/PA (Corrective and Preventative Actions) โ improvement to laboratory systems for instrument calibration/qualification, implementation of controls to prevent microbiological contamination of product, procedural simplification
-Mentor investigators and QA team members for technical writing, investigation techniques, identification of realistic CA/PAs, and scope of product impact
-TrackWise