About this role
Job Description Summary This role will provide scientific and operational support to Study Quality and Compliance group within PreClinical Safety (PCS) function. Job Description Major Accountabilities:
• Ensuring PCS compliance with training records, CV, and JDs. • Ensure all documentation is consistent with GLP requirements. • Support periodic review and maintenance of PCS SOPs. • Maintain good working knowledge of any company SOPs that influence or impact the PCS SOPs. • Get necessary input/feedback from relevant stakeholders to keep documentations up-to-date· • Create and perform quality checks on SEND packages for FDA submissions • Support electronic laboratory notebook compliance ensuring the necessary reviews and compliance with company guidelines • Support the Study Quality and Compliance team’s effort for tracking and managing study-related information in a global online fashion by leveraging the use of software tools to enhance productivity and information sharing.
Minimum Requirements:
• Graduate/ Postgraduate in Life Sciences with 10-15 years relevant experience working in pharmaceutical GLP setting. • Good working knowledge of regulatory compliance requirements • Knowledge of animal welfare requirements related to study conduct
• Previous experience creating and reviewing SEND packages • Good communication skills, and excellent logistical/planning skills • Previous experience with software for online information and program management is a plus
Skills Desired Animal Models, Bioinformatics, Collaboration, Communication Skills (Inactive), Data Analysis, Ethics, Laboratory (Inactive), Problem Solving, Regulatory Compliance, Researching, Risk Assessments, Toxicology