At Fujifilm, I developed and revised more than one hundred qualification and verification documents for manufacturing and laboratory environments. I also developed Validation Master Plans and Validation Project Plan protocols that supported the launch of ProjectAura.
I work with subject-matter experts, including lab scientists and process engineers, to turn complex analytical methods and tech transfer data into executable work instructions. At Merck and Guerbet, I wrote and managed documentation changes and supported deviation investigations, root cause analysis, and CAPAs.
Across pharma and biotech roles, I’ve worked on SOPs, document control, and quality records. My experience also includes supporting downstream purification at Biogen and aseptic filling at Grifols.
