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QA Specialist II

Quality & Laboratory
Cork
Siobhán Lane
Temporary
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Job Reference: JO-2007-65283_1594135362

Summary:



Responsibilities:


As part of team of other QA specialists, the candidate may be responsible for performing a wide variety of activities to ensure compliance with applicable regulatory requirements for:



  • Leading customer complaint investigation coordination

  • Leading of investigations and corrective and preventive actions (CAPA)

  • Compiling data for annual product quality reviews and generates and reports on site quality system metrics

  • Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.

  • Works directly with cross-functional departments to ensure that quality system requirements are met

  • Participates in the development of training programs regarding all aspects of producing quality products

  • Participates in the completion of internal audits and walkthroughs

  • Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)

  • May act as a lead QA support and signoff for projects and related validation activities

  • May provide support for onsite departments in assessing and approving changes and deviations related with IT and electronic systems



Requirements:



  • 4+ years of relevant experience in a GMP environment related field and a BS.

  • 2 + years of relevant experience and a MS.

  • Prior experience in pharmaceutical industry is preferred

  • Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.

  • Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.



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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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