Quality Specialist III

  • Cork
  • Temporary 12 months
  • JO-1902-64270_1550567488

Summary

Responsibilities

  • Participates within inter-departmental and cross-functional teams
  • Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
  • Reviews routine data for release of starting materials / packaging components
  • Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
  • Identifies problems and generates alternatives and recommendations
  • Serve as a lead of investigations and corrective and preventive action (CAPA) plans
  • Completion of routine to more complex/non-routine projects/assignments
  • Normally receives very little instruction on routine work, general instructions on new assignments
  • Writes and/or implements changes to controlled documents

Requirements

  • Prior experience in pharmaceutical industry is preferred (ideally within a QA role)
  • Quality / Science Qualification essential and 5+ years' relevant experience
  • Demonstrates working knowledge of quality assurance systems, methods and procedures within a cGxP environment
  • Demonstrates audit and investigation skills, and report writing skills
  • Demonstrates knowledge of Lean practices and root cause analysis
  • Demonstrates good verbal, written, and interpersonal communication skills
  • Demonstrates proficiency in Microsoft Office application
  • Ability to engage and manage multiple stakeholders to achieve the objective
  • Operationally excellent
  • Organised with systematic approach to prioritisation
  • Process orientated to achieve the business objective

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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The Life Science Specialists

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