Website Asset Recruitment

Asset Recruitment

Ref: 00877

QA Validation Engineer

Duties

This position provides senior level support to the QA Validation function

Provide quality oversight of facility and equipment commissioning and qualification activities.

  • Provide technical assessments on management of change, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
  • Provide quality oversight of engineering and validation studies, and review and approval of protocols and summary reports.
  • Use project management skills to drive results and achieve expected timelines and outcomes.
  • Represent the QA team on project core teams and participate in strategy discussions aligned with global initiatives and regulatory requirements.
  • Support regulatory inspections and inspection readiness activities.

Responsibilities:

  • Provide quality oversight and ensure GMP compliance for engineering and validation deliverables related to site projects (Compliance, Improvement, etc.)
  • Provide QA reviews for definition, specification, engineering design, qualification, cleaning and manufacturing process validation, and change management.
  • Serve as point of contact for client/PM  to identify project needs and ensure practices are consistent with quality and regulatory standards.
  • Support site continuous improvement initiatives

Education /Experience

  • 5+ years of industry experience in a pharmaceutical GMP environment.
  • BS in Engineering and / or Science
  • Minimum 3 years project support experience with increasing responsibility in the areas of Quality Assurance.
  • Knowledge of FDA and EMA regulations and a working knowledge of statistical analysis and root cause analysis is required.
  • Excellent interpersonal skills and strong oral and written communication.
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