Senior Quality Assurance Specialist

2 weeks ago


Hong Kong, Central and Western District, Hong Kong SAR China Parexel Full time
Job Title: Senior Quality Assurance Specialist

About the Role:

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Parexel. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality and compliance in our operations.

Key Responsibilities:
  • Lead and coordinate internal audits and audit programs, including planning and conducting complex audits across all phases of Clinical Research.
  • Manage tasks and initiatives, including teams of multifunctional personnel, as needed.
  • Develop and execute strategic audit plans for specific areas of specialization.
  • Act as a key contributor for review of client audit/regulatory inspection findings.
  • Provide consultation and interpretation on regulatory compliance to internal/external clients, Parexel management, and staff.
  • Act as a contact with members of Regulatory Authorities and/or clients; lead their audits/inspections in agreement with QA management.
  • Travel internationally for audits as required.
Requirements:
  • Proven experience in Quality Assurance and regulatory compliance.
  • Strong knowledge of GxP regulations and industry standards.
  • Excellent communication and leadership skills.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.
What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

About Parexel:

Parexel is a leading global biopharmaceutical services company that provides a comprehensive range of solutions to help clients accelerate the development and delivery of new and innovative treatments.



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