Sr. Operations Quality Engineer - Raleigh - Endo International

    Endo International
    Endo International Raleigh

    3 days ago

    Description

    Endo-International Quality Engineer

    We're looking for a passionate and talented individual who shares our commitment to improving lives. Our team of 4,000+ members worldwide prioritizes quality and safety while fostering a culture of continuous improvement, accountability, and teamwork.

    Job Description Summary

    • The Sr. Quality Engineer has responsibility for interpreting and applying regulations and developing standard operating procedures (SOPs) to ensure delivery of the highest quality product to customers.
    • This role provides input into regulatory filings as well as guidance for various elements of the Quality System including validation, deviations, supplier quality, product complaints, internal audits, OOS/CAPA/Annual Product Review/process control/change control,and identification/recommendations for continuous improvement opportunities(internal/external).

    In this role you will:



      included identifying root cause develop corrective actions effectively.
      guidance on data trending models using appropriate statistical methods deploying their use.
      nalyze trends related to various activities identify root causes areas improve
      utilize output trend analysis initiate investigations or corrective/preventive action projects?
      draft /revise SOPs,policies,take ownership day-to-day metrics/trending.
      Cross functional teams complaint investigation/resolution final reports document
      L investigate/support conclusions lead CAPA initiatives resolve issues efficiently/effectively
      The successful candidate will have:
      Bachelor's degree in engineering/science or related field,
      a minimum 5 years QA/pharmaceutical manufacturing environment experience,
      Knowledge ICH Guidelines (Q7,Q8,Q9,Q10), FDA EMA USP EP JP;

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