Bausch Health

  • Senior Software Quality Engineer

    Job Location US-FL-Tampa
    Job ID
    10323
    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.

     

    The software quality assurance engineer is responsible for assuring that computerized systems associated with the manufacture of pharmaceutical product is validated in accordance with regional and local procedures and cGMP regulation and guidelines. Job assignments are to be completed without a considerable amount of supervision or coaching.

     

    This position will assume responsibility for the implementation and validation of computerized systems associated with the manufacture of pharmaceutical product.

    Responsibilities

    • Maintain a list of all computerized systems that are used in the manufacture of pharmaceutical product.
    • Assure 21 CFR Part 11 pre- and post-assessments are performed on all systems.
    • Assure that computerized systems are released to production in accordance with regional and local procedures.
    • Review and approve validation documentation, including    assessments, validation plans and reports, requirements,   specifications, protocols and reports, test scripts and discrepancies.
    • Assure that computerized systems are in the requalification program and are part of the program for security access review.
    • Provide guidance to project teams on the deliverables required as part of the validation package.
    • Assure that all computerized systems are compliant with regulatory guidance's, including 21 CFR Part 11 and Data Integrity.

    Qualifications

    • 5 or more years of computerized systems/SQA experience is required.
    • Strong organizational, analytical, computer, writing, and communication skills.
    • Project management is a plus.
    • Knowledge of aseptic manufacturing experience is highly desired.
    • Excellent logical/mechanical aptitude is desired.
    • Knowledge of cGMP regulations and latest validation guidelines.
    • Able to handle multiple priorities in a fast-paced environment.
    • Able to work extended/flex hours around the manufacturing schedule.

     

    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.

    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.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed