Valeant Pharmaceuticals

  • Clinical Quality Specialist

    Job Location US-NY-Rochester
    Job ID
    10740
    Pos. Category
    Quality
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

     

    CQA team member responsible for enhancing the quality of clinical research trials through the support of clinical quality assurance initiatives.

     

    Support the Clinical Quality Assurance function within Research and Development Operations with responsibility for managing audit program including audit schedules, audit records and CAPAs in the CQMS system, and conducting TMF audits ensuring clinical trials supporting pharmaceutical and medical device registrations are conducted in compliance with all applicable regulations.

    Responsibilities

    • Manage audit schedules, audit records, and CAPA tracking.
    • Support auditees in developing effective, risk based corrective actions.
    • Support internal and regulatory inspections.
    • Authors/reviews summary reports, memos and standard operating procedures.
    • Conduct system, study, site and vendor audits.
    • Partner with key customer groups in clinical operations to develop and meet quality objectives.
    • Key Relationships: R&D Clinical Operations, North America Region Global Product Surveillance Department, North America Region North America Quality (ie. Compliance Quality Regulatory Affairs), Clinical Quality Consultants and Contractors, External Regulatory Agencies

    Qualifications

    • Minimum BS/BA in related field
    • Working knowledge of GxP regulations/ guidelines (ICH, US FDA, ISO)
    • Strong computer skills
    • Excellent communication (verbal and written) skills and ability to work effectively on teams.
    • Excellent organization skills.
    • Minimum 2 years’ experience in related healthcare, medical device or pharmaceutical industry.

    Be Aware of Recruiting Fraud

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

     

    To learn more please read Valeant’s Job Offer Fraud Statement.

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