QA Auditor II

4 weeks ago


Bengaluru, Karnataka, India Labcorp Full time

Responsibilities:

  • Reviewing study protocol reviews, data and report audits for Toxicology, Safety Assessment and Pharmacology studies.
  • Conducting internal inspections (study, process, facility based).
  • Evaluating Standard Operating Procedures.
  • Developing and providing training to operational groups and QA.
  • Offering advice on quality and compliance aspects.
  • Collaborating on Quality and compliance improvements.
  • Supporting Quality topics with operational management.
  • Managing local Quality initiatives to enhance compliance and efficiency.
  • Ensuring compliance with Regulatory Compliance and Quality Assurance responsibilities.

Experience Requirements:

  • Bachelor's Degree in Life Sciences preferred (or equivalent experience).
  • At least 2 years in a regulatory environment.
  • QA Experience in GLP Toxicology studies on small animals/non-rodents preferred.
  • Experience in GLP QA Auditor roles in a regulatory environment desired.
  • Inspecting and auditing animal Toxicology, Safety Assessment or Pharmacology studies is a plus.
  • Knowledge of OECD GLP quality systems/standards and regulatory compliance.
  • Experience in process improvement.
  • Strong communication skills and ability to provide clear feedback and training.
  • Experience in initiating process improvement initiatives and offering solutions.
  • Able to work in 2nd shift hours ie., 2:30 PM to 11:30 PM IST.

About the Company:

Labcorp values diversity, inclusion, and equal opportunities. We do not tolerate any form of harassment or discrimination. Our employment decisions are based on business needs and individual qualifications, without bias towards any legally protected characteristic. We welcome all candidates to apply.

For information on personal data collection and privacy, please refer to our Privacy Statement.



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