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QA Specialist Senior

Reference ID : NHA91
Category :
  • Pharma / Biotech
  • Science
  • General Manufacturing
  • Medical Devices
Date Posted : Sep 19, 2019
Job Location
  • Leinster
- Dublin
Experience : 4+ Yrs
Salary : Neg
Employment Type
Nicola O'Sullivan
Contact Number : 087 0622429
Senior QA Specialist required for Dublin based biopharmaceutical multinational.

Principal Responsibilities

QA Specialist Senior 

This is a Dublin based role within a leading pharmaceutical multinational.  The QA Specialist will be required to provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes.

Key Responsibilities 
• Manage and own NC records for External Quality 
• Manage and own CAPA records for External Quality 
• Manage and own Change Control records internal to External Quality 
• Manage and drive Quality records to closure independently 
• Perform tactical batch disposition activities in support of lot release 
• Escalate risks or roadblocks to management 
• Drive continuous improvements
• Engage &/or participate with ongoing improvement initiatives within the Regional work cell and the wider organisation 
• Create and foster an environment of change and development within the Regional Work Cell and seek to influence beyond. 
• Create and foster key relationships to enable timely completion of activities and responsibilities. 

Qualifications & Requirements

Preferred Qualifications: 
• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry 
• Bachelor’s Degree in a Science Field 
• cGMP Experience 
• Ability to oversee multiple projects simultaneously 
• Able to successfully manage workload to timelines 
• Demonstrated ability to consistently deliver on-time, and high-quality results 
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) 
• Ability to travel +/- 10% of time to domestic and international sites

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

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