Senior Quality Assurance Auditor

7 days ago

Hong Kong, Central and Western District, Hong Kong SAR China Parexel Full time
Job Title: Senior Quality Assurance Auditor/Compliance Manager

About the Role:

Parexel is seeking a highly skilled Senior Quality Assurance Auditor/Compliance Manager to join our team. 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:Quality Assurance and Compliance
  • Lead and work independently and as part of the QA team to ensure compliance with regulatory requirements and Parexel SOPs.
  • Act as expert GxP consultant in relevant areas to groups within the Parexel organization and Parexel clients.
  • Promote compliance within the company and represent QA, as required.
  • Review Parexel SOPs to ensure GxP compliance of processes.
  • Proactively review and oversee QA SOPs and be able to speak to their contents.
Regulatory Compliance and Audits
  • Work closely with Regulatory Authorities and Clients to support regulatory inspections and client audits.
  • 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.
  • Act as key contributor for review of client audit/regulatory inspection findings.
Quality Assurance Leadership
  • Lead and coordinate internal audits and audit programs (global and regional).
  • Plan and conduct complex/for cause audits as assigned across all phases of Clinical Research.
  • Coordinate internal global process/system audits across regions and develop all necessary tools.
Process Improvements and Training
  • Optimize new and existing processes to maintain and improve quality standards.
  • Assist QA Management in the development and implementation of audit plans, strategic procedures, and working practices.
  • Develop and present training courses as needed.
Relationship Building and Communication
  • Build, develop, and maintain good working relationships with internal and external customer groups.
  • Work well in a team environment.
  • Liaise with clients and operational staff on quality aspects.

About Parexel:

Parexel is a leading global biopharmaceutical services organization. We provide a comprehensive range of services to help our clients succeed in drug and medical device development.

What We Offer:

Parexel offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to attracting and retaining the best talent in the industry.

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