QA Specialist III

  • Cork
  • Temporary 12 months
  • JO-1902-64232_1549535892

Summary

Responsibilities

  • Perform as the QA representative for all stages of two automation projects, supporting qualification and validation activities as per project timelines in accordance with site procedures and GMP guidelines
  • Provide QA advice and support to the project teams as required to ensure compliance with applicable regulatory requirements
  • Participates in developing and approving SOPs to ensure quality objectives are met
  • May conduct or serve as lead of investigations and CAPA recommendations related to manufactured products
  • Develops solutions to more complex problems and identifies deviations from accepted practices and evaluates impact assessment as required
  • Normally receives no instruction on routine work and general instructions on new assignments.

Requirements

  • Prior experiences in a pharmaceutical industry is preferred, guideline of 6+ years in relevant field with appropriate BS or BA qualification.
  • Demonstrates proficiency in GMPs
  • Demonstrates proficiency in the application of QA principles, concepts, industry practices and standards
  • Demonstrates thorough knowledge of FDA and EMA standards and quality systems and interfaces with other site functions
  • Demonstrates strong knowledge of six sigma and root cause analysis tools used for identifying and correcting deviation
  • Demonstrates investigation skills, report writing skills, strong verbal, technical writing and interpersonal skills

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