Quality Specialist II

  • Cork
  • Temporary 12 months
  • JO-1902-64271_1550568165

Summary

Responsibilities

  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements
  • Coordinates and writes annual product reviews
  • Supports changes in processes and systems through change control review and review of related validation documentation
  • Participates in developing SOPs to ensure quality objectives are met
  • Ability to recognize deviations from accepted practice is required
  • Conducts or serve as lead of investigations and CAPA recommendations related to manufactured products and systems used
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP)
  • May participates in the tracking and completion of product complaint investigations
  • Participates within inter-departmental and cross-functional teams
  • Normally receives very little instruction on routine work and general instructions on new assignments.

Requirements

  • Prior experience in pharmaceutical industry is preferred
  • Demonstrates working knowledge of quality assurance systems, methods and procedures
  • Demonstrates investigation skills, report writing skills, strong verbal, technical writing and interpersonal skills
  • Demonstrates basic knowledge of Lean practices and root cause analysis
  • Demonstrates working knowledge of current Good Manufacturing Practices (GMPs)
  • Demonstrates proficiency in Microsoft Office applications.

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