QA Specialist II

  • Cork
  • Permanent
  • JO-1902-64222_1549295248

Summary

Responsibilities

  • Participates within inter-departmental and cross-functional teams
  • Performs a variety of activities to ensure compliance with applicable regulatory requirements
  • Participates in developing/updating Standard Operating Procedures (SOPs) to ensure quality objectives are met
  • Ability to recognize deviations from accepted practice is required
  • Exercises judgment within defined procedures and practices to determine appropriate action
  • Identifies problems and generates alternatives and recommendations within defined processes
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
  • May conduct or serve as a lead of investigations and corrective and preventive action (CAPA) plans related to materials
  • Assignments may range from routine to more complex/non-routine projects/assignments, where analysis of situation or data requires a review of identifiable factors
  • Normally receives very little instruction on routine work, general instructions on new assignments
  • Coordinates, plans, implements projects within specified objectives




Requirements

  • Quality / Science Qualification essential and 4+ years' relevant experienc
  • Prior experience in pharmaceutical industry is preferred.
  • Demonstrates working knowledge of quality assurance systems, methods and procedures
  • Demonstrates audit and investigation skills, and report writing skills
  • Demonstrates basic knowledge of Lean practices and root cause analysis
  • Demonstrates good verbal, written, and interpersonal communication skills

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The Life Science Specialists

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