Valeant Pharmaceuticals

  • Senior Computer Systems Quality Assurance Engineer

    Job Location US-NY-Rochester
    Job ID
    10295
    Pos. Category
    Quality
    Pos. Type
    Full Time
  • 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.

     

    Overview of the role:

    • Global and regional enterprise-wide electronic systems involved in GMP activities; specific to Quality Systems
    • Advance and implement the Computer Systems Quality Assurance operating framework that aligns regulatory agencies compliance and the company’s quality expectations, business goals and objectives.   
    • Ensure adherence to and continuous improvement of the System Development Life Cycle processes
    • Provide day-to-day guidance and support to the computer systems validation team and interfacing with Program Managers and other team leaders

    Responsibilities

    • Guidance and support Project Managers throughout the project lifecycle in the implementation, verification and validation of GxP and enterprise computer systems, its documentation to ensure compliance to Project, Internal and External requirements.
    • Create and maintain Computer Systems Quality Assurance documentation for GxP and enterprise computer systems
    • Improve Computer Systems Quality Assurance operating framework to include policies, SOPs (Standard Operations Procedures) WIs (Work Instructions) and reference documents to optimize usability and ensure successful Project and Internal and FDA audit results
    • Facilitate System Development Life Cycle (SDCL) training classes that educate Project Managers and teams on Computer Systems Quality Assurance topics and ensure compliance with internal and external regulation and requirements.   
    • Collaborate efforts with the training team to ensure deployment of competency training specific to System Development Life Cycle (SDCL)
    • Participate in Internal and Regulatory audits, as required
    • Perform application remediation activities, as required
    • Provide Project Management assistance, if required
    • Maintain an effective Software System Lifecycle process through periodic assessments
    • Promote and support Change Management Process
    • Participate on project teams to assure the adequacy and compliance of Software Quality activities
    • Ensure adherence to Best Practices and Industry Standards
    • Key Relationships: Quality Business Unit Leaders, Site Quality Leaders and staff, and Software Quality specialists, Enterprise and Site Operations/Engineering, IT, R&D Leaders and other personnel; external vendors

    Qualifications

    • 5-10 years of experience in computer validation;
    • 5-10 years hands-on experience with Software Quality in a GxP regulated environment;
    • Experience with auditing Software Quality Management Systems
    • Experience with leading successful teams, maintaining schedules, dealing with resource constraints, providing guidance, and with identifying and recommending changes to established practices
    • Strong written and oral communication and interpersonal skills
    • Good team player with ability to work independently
    • Ability to multi-task

    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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