Seeking experienced Contamination Control Auditors with expertise in Annex 1 projects to conduct gap assessments and report writing. Candidates should possess a Bachelor's degree in Microbiology, over 10 years in pharmaceutical Quality Operations, and strong knowledge of regulatory guidelines and cGMPs. Strong technical writing and communication skills are essential.

The TMF Study Owner is responsible for ensuring consistent and compliant clinical trial documentation related to Trial Master Files. They lead the development of TMF specifications, monitor document quality, provide audit support, identify improvement opportunities, and collaborate with study teams to enhance documentation practices and regulatory compliance throughout clinical trials.