Labcorp is seeking a Contributing Scientist to join our team in Bangalore, India. In this role, you will maintain in-depth knowledge of national and international GLP/GCP regulations and their application to laboratory operations. You will be responsible for ensuring regulatory compliance, managing study documentation, and contributing to the evaluation and interpretation of complex data for study reports.
Key Responsibilities
- Regulatory Compliance:
- Maintain training records and ensure appropriate Controlled Copy Lists (CCLs) are in place.
- Keep reading/training materials up to date and ensure compliance with regulatory guidelines (e.g., OECD, GxP, Home Office license).
- Data Evaluation and Project Management:
- Apply expertise in complex data evaluation and interpretation for study reports.
- Review and approve critical aspects of projects/studies, including procedures and analysis strategies.
- Monitor progress and status of assigned studies, ensuring accurate recording and verification of experimental data, including observations of unanticipated responses to test systems.
- Project Ownership:
- Take ownership of assigned projects, ensuring on-time delivery of protocols, results, reports, and audit responses in accordance with predefined timelines.
- Technical Knowledge and Collaboration:
- Demonstrate knowledge of assays and procedures, discussing techniques with support from trained personnel during cross-training, inspections, or audits.
- Perform peer review of reports to ensure quality and compliance.
Qualifications
- Strong understanding of GLP/GCP regulations and their practical application.
- Proven experience in data evaluation, study documentation, and project management.
- Excellent analytical and problem-solving skills.
- Ability to collaborate effectively with team members and external stakeholders.
