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Senior QA Specialist

Reference ID : NHA93
Category :
  • Pharma / Biotech
  • General Manufacturing
  • Science
  • Medical Devices
Date Posted : Dec 19, 2017
Job Location
  • Leinster
- Dublin
Experience : 8+ Years
Salary : Neg
Employment Type
Nicola O'Sullivan
Contact Number : 087 0622429
Senior QA Professional required for

Principal Responsibilities

Senior QA Specialist

An opening for a Senior QA Specialist has arisen within a leading Dublin based pharmaceutical multinational.  The successful candidate will provide overall quality direction for key functional areas including process development, validation, quality control, supply chain, engineering and information systems.

Key Responsibilities:

  • Perform all activities in compliance with site safety standards and SOPs
  • Provide quality direction and input at change control and NC review boards and assume oversight of change control and NC/CAPA records
  • Write, review and approve SOPs
  • Participate in site activities associated with QMS programmes
  • Participate in customer complaint investigations
  • Act as quality point of contact during Tech Transfer and Process Validation activities
  • Act as quality point of contact for CSV activities
  • Quality SME reviewer/approver for regulatory submissions ensuring compliance with site and corporate procedures.

Qualifications & Requirements

Qualifications and Experience:

  • University Degree in an Engineering or Science discipline
  • 8+ Years working in the pharmaceutical or Biotech industry
  • Detailed knowledge of applicable regulatory requirements, experience with regulatory inspections
  • Experience working in aseptic operations, protein formulation, vial and syringe filling
  • CSV experience would be an advantage
  • Excellent written and verbal communication skills
  • Strong organizational skills

For more information and a full job spec contact Nicola on 087 0622429 or email your CV in the strictest confidence to jobs@headcount.ie

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