QA Specialist II

  • Cork
  • Temporary 12 months
  • JO-1905-64507_1561646572

Summary

Responsibilities

  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • 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) and Good Laboratory Practices GLPs).
  • Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
  • Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
  • Works with Research and Development during new product start-ups, and identifies checkpoints for new products and processes.
  • Normally receives very little instruction on routine work, general instructions on new assignments.

Requirements

  • Quality / Science Qualification essential
  • Prior experience in pharmaceutical industry
  • Demonstrates thorough knowledge of FDA / EMEA standards and quality systems,
  • 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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