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Job

Quality Manager

  • Job ref:

    8506

  • Location:

    Boston, United States

  • Sector:

    Quality Engineers

  • Contact:

    Stephanie Borjeson

  • Published:

    8 months ago

Quality Manager 

  • Validation Activities: Provides QA support in validation strategy meetings related to facility, utility, automation, equipment and QC Lab operation activities.
  • Change control: Provides QA support on change controls.
    • Leads and manages change control proposal meetings.
    • Reviews for execution approval of change controls per change control SOP.
    • Performs final review and approval of change controls..
  • Performs QA changeover requirements and maintains documentation.

POSITION REQUIREMENTS:

  • Strong knowledge of 21 CFR, ICH, and EU regulations
  • Strong knowledge of Risk Based approach and performing Risk Assessments
  • Strong interpersonal and communication skills and the ability to work effectively a diverse community.
  • Proficient at public speaking and teaching
  • Recognize, understand and respond to situations
  • Understand operational documents for GMP compliance, accuracy and completeness.  
  • Function in a dynamic environment and balance multiple priorities simultaneously.

EDUCATION AND QUALIFICATIONS:

  • Bachelor’s Degree in Sciences or Education
  • Minimum 8 years’ industry related experience with a Bachelor’s Degree
  • Strong interpersonal and communications skills; written and oral
  • Solid understanding of applicable regulatory requirements