Valeant Pharmaceuticals

  • Quality Assurance Project Manager

    Job Location US-FL-Tampa
    Job ID
    9757
    Pos. Category
    Quality
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse and decentralized 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.

     

    Provide support for pharmaceutical development projects from project inception through successful technology transfer/scale-up at the ultimate manufacturing facility. The role includes working with multidisciplinary teams to ensure pharmaceutical development activities are planned and executed in compliance with GMP standards, policies and   procedures.

    Provide local quality assurance support to Tampa R&D organization.

     

    No direct report. 

    Responsibilities

    • Ensure new product introduction project plans adequately address GMP and Quality departmental requirements and standards. Work with functional    departments to ensure plans are executed compliantly.
    • Facilitate GMP Quality activities at B+L, CRO/CMO sites to ensure timely and compliant delivery of product and data. Assure GMP standards and B+L policy are met.
    • Review/approve GMP documents to ensure clinical material meets compliance expectations.
    • Facilitate GMP product readiness and launch activities, including stability strategy, technology transfer and validation.
    • Depending on R&D support, perform MOB activities as appropriate, including method transfers in support of global expansion.
    • Develop and implement quality systems to support the new R&D equipment / new product line.
    • Single Point of Contact in Tampa for R&D Quality in support of     
    • R&D specific work related to new product development.
      • Investigations / Deviations
      • Support method validations and transfers (analytical / micro) from Rochester R&D
      • Support technology/process transfer activities
      • Review and approve batch documentation in support of clinical trial material production
      • Approval of protocols and final reports for cleaning and process validations
    • Develop and track R&D Metrics / measuring system to support the Global R&D Quality Plan. Work with customer groups to implement corrective actions in response to negative trends.
    • Key Relationships: Regulatory Affairs, Project Teams, R&D leaders in pharmaceutical business, site leadership in quality, operations, and external manufacturing groups.

    Qualifications

    • Bachelor’s degree BS in scientific discipline (Chemistry, Biology, Microbiology or related field) with 10 years relevant experience, graduate degree a plus.
    • Pharmaceutical GMP regulations and guidelines.
    • Analytical Method development (desired, not required).
    • Statistical analysis, Minitab knowledge a plus (QE tools).

    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.

     

     

    Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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