QA Manager job in shanghai, , China

Full Time Shanghai Covance

Job Overview:

  • Perform all of the activities required to host client audits.
  • Review and approve responses to audit/ inspection findings and provide guidance and support to ensure proper corrective and preventive measures are included
  • Assist in the tracking of client issues identified from client audits in Veeva system
  • Conduct internal training s it relates to providing clients with information during audits
  • Analyze tracking and trending of issues related to client audits
  • Assist with mentoring the Client Interactions new hires
  • Review and approve audit responses to CAPAs
  • Ensure client audit reports are completed in a timely manner
  • Assist with the completion of client audit questionnaires
  • Participate in the design and implementation of appropriate solutions and process improvements which enhance customer satisfaction
  • Quality Assurance
    •     Participate in revision of Client Interactions SOPs
    •     Support development of processes and SOPs by processes   owners outside CQA

Education/Qualifications:

  • University / College degree, BA/BS (life science preferred) or equivalent experience
  • Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
  • Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
  • Knowledge of the drug development process from the perspective of a contract research organization
  • Experience in Facilitating Client Audits

 

Experience:

Five to eight years of experiences in pharmaceutical / CRO industries or in a medical / clinical / laboratory or other scientific role

Good analytical skill

Excellent oral, written and presentation skills

Proven interpersonal skills

Ability to function as a member of a global clinical team

 

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