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
