Position Description

Minimum of Bachelor's Degree in Science or Engineering, or related. Role will require focused expertise in sterile operations, quality and laboratory controls to improve SOPs associated with CAPAs and to initiate Change Controls, as applicable.

Key Skills:
• Knowledge and understanding of Pharmaceutical GxPs and excellent cGMP documentation skills
• Strong writing aptitude and ability to review technical documents
• Review proposed changes that might affect validated or controlled status of manufacturing practices
• Draft SOPs in response to CAPAs and initiate the associated change controls