Senior Quality Assurance Auditor

1 month ago


Nagpur, Maharashtra, India Parexel Full time
Senior Quality Assurance Auditor

At Parexel, we are seeking a highly skilled Senior Quality Assurance Auditor to join our team of experts in clinical research. As a Senior Quality Assurance Auditor, you will play a critical role in ensuring the quality and integrity of our clinical research operations.

Key Responsibilities:
  • Lead and perform GxP audits across all phases of clinical research
  • Develop and execute strategic audit plans to ensure compliance with regulatory requirements
  • Manage and coordinate internal regional and global process/system audits
  • Report outcomes and trends of audit programs to QA Senior Management
  • Review audit reports, responses, and other program deliverables to ensure high-quality standards
  • Act as QA Lead on audits programs
  • Support Serious Breaches (SB) investigations and oversee project teams to reach final conclusions
  • Support auditor training and mentoring of new/less experienced auditors
  • Maintain QA records/systems and process improvements
  • Provide local, regional, and global consultancy and interpretation on regulatory compliance
  • Support Sponsor Audits and Regulatory Inspections
Requirements:
  • Minimum of 2 years' experience in quality assurance, auditing, including sound experience of applicable GxP auditing
  • At least 5 years' experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science
  • Ability to travel internationally for audits as required (up to 60% travel time)
  • Excellent knowledge, understanding, and experience of Good Practices (GxPs) and international, national, and local regulations and laws related to clinical trials and other clinical research
  • Ability to rapidly learn, understand, and apply applicable Parexel and client procedures
  • Client-focused approach to work
  • Excellent interpersonal, verbal, and written communication skills
  • Ability to mentor/train auditors and other personnel
  • Flexible attitude to work assignments and new learning
  • Ability to diplomatically address sensitive issues confidentially and professionally
What We Offer:
  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Collaborative and inclusive work environment
  • Flexible working hours and work-life balance
  • Pet insurance and other employee benefits

Parexel is an equal opportunity employer and welcomes applications from qualified candidates without regard to legally protected status.



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