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The job will involve:

Conducting regulated study protocol reviews, data and report audits for Toxicology and supporting Dose Analysis Analytical chemistry audits

• Follow applicable approved policies and SOPs

• Navigate to the regulations and able read/understand specific regulations

• Perform review of protocols/amendments and report audits.

• Timely notify management regarding identification of critical issues.

• Able to understand regulatory requirements and issue audit findings (successful interaction/relationships on small scale outside QA function)

• Make suggestions for improving compliance and/or efficiency of the local QA

• organization and business units supported

• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed

• Other duties as assigned by management.

Experience:

• A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)

• 2+ year in a regulatory environment

• QA Experience in GLP Toxicology studies on small animals/non-rodents and/or Dose formulation analysis preferred along with understanding of importance of concentration analysis in GLP study

• Experience in regulatory environment as GLP QA Auditor roles desired.

• Experienced in inspecting and auditing animal Toxicology and supporting dose analysis analytical part.

• Knowledge of the OECD GLP quality systems/standards and able to apply regulations in order to monitor compliance.

• Clear communication skills, including ability to provide clear feedback.

• Able to clearly articulate processes in order to provide training.

• Able to influence process improvement initiatives / offer solutions.

• Should be fine with working in 2nd shift hours i.e., 2:30 PM to 11:30 PM IST

Labcorp is proud to be an Equal Opportunity Employer:

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