Senior Quality Assurance Specialist

23 hours ago


Nagpur, Maharashtra, India Parexel Full time

About the Role:


Parexel seeks a seasoned Senior Quality Assurance Auditor to join our team of dedicated professionals driving excellence in clinical research.


Key Responsibilities:



  • Lead, perform, and report audits for area of specialization, working closely with internal customers to develop and execute strategic audit plans.
  • Manage GxP audits, ensuring compliance with international, national, and local regulations and laws.
  • Develop and maintain good working relationships with internal and external customer groups.
  • Support Sponsor Audits and Regulatory Inspections, as assigned.
  • Collaborate with cross-functional teams to identify and implement process improvements, maintaining and enhancing quality standards.
  • Provide local, regional, and global consultancy and interpretation on regulatory compliance to internal and external clients.
  • Liaise with external industry and regulatory inspectorate contacts to determine best practices regarding implementation of relevant GxP requirements.

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, with approximately 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.
  • Excellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings, and training sessions.
  • Ability to diplomatically address sensitive issues confidentially and professionally.

About Us:


Parexel is a leading Clinical Research Organization (CRO) company, dedicated to advancing healthcare globally while keeping the patient at the heart of everything we do. We offer a collaborative and inclusive work environment, professional growth and development opportunities, work-life balance, and flexible working hours.


Parexel Benefits:



  • Health, Vision, and Dental Insurance
  • Tuition Reimbursement
  • Vacation/Holiday/Sick Time
  • Flexible Spending and Health Savings Accounts
  • Work/Life Balance
  • 401(k) with Company Match
  • Pet Insurance


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