QA Auditor

3 days ago


Bengaluru, Karnataka, India Labcorp Full time

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:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility.

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