QA Specialist

  • Cork
  • Temporary 18 months
  • JO-1903-64350_1556285360

Summary

Responsibilities:

  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements through support of Packaging and Engineering functions.
  • Works directly with Packaging and Engineering functions to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • Reviews routine Packaging and Engineering documents including tech trial protocols and reports
  • Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to packaged products.
  • Reviews and evaluates proposed changes, qualification and validation documentation as related to engineering and manufacturing.
  • May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
  • May assist with compliance audits as required.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
  • Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.
  • Normally receives no instruction on routine work, general instructions on new assignments.


Requirements

  • 6+ years of relevant experience in a GMP environment related field and a BS or BA.
  • 4+ years of relevant experience and a MS.
  • Demonstrates proficiency in Good Manufacturing Practices (GMPs).
  • Previous experience with Change Management, Validation and Commissioning
  • Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like packaging and engineering.
  • Demonstrates strong 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.

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