Quality Specialist II

  • Cork
  • Temporary 12 months
  • JO-1902-64271_1562573783

Summary

Required to primarily support the compilation of data for annual product quality reviews, site Quality System metric generation and reporting, QA support for system changes and associated validation activities and issues as well as customer complaint investigations.

Responsibilities

  • Compiling data for annual product quality reviews and generates and reports on site quality system metrics
  • Leading customer complaint investigation coordination
  • Leading of investigations and corrective and preventive actions (CAPA)
  • Acts as a lead QA support and signoff for projects and related validation activities
  • Provides support for onsite departments in assessing and approving changes and deviations related with IT and electronic systems

Other activities may include:

  • Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
  • Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
  • Works directly with operating entities to ensure that quality system requirements continue to specifications.
  • Participates in the development of training programs regarding all aspects of producing quality products.
  • Normally receives very little instruction on routine work, general instructions on new assignments.

Requirements:

  • 4+ years of relevant experience in a GMP environment related field and a BS.
  • Demonstrates working knowledge of current Good Manufacturing Practices (GMPs)
  • Demonstrates working knowledge of quality assurance systems, methods and procedures.
  • Demonstrates knowledge of FDA / EMEA standards and quality systems.
  • Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
  • Demonstrates audit and investigation skills, and report writing skills.
  • Demonstrates good verbal, written, and interpersonal communication skills.

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