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Senior Associate QC Specialist

Reference ID : NHA94
Category :
  • Medical Devices
  • Pharma / Biotech
  • Science
  • General Manufacturing
Date Posted : Aug 13, 2019
Job Location
:
  • Leinster
- Dublin
Experience : 4+ Yrs
Salary : Neg
Employment Type
:
Contract
Consultant
:
Nicola O'Sullivan
Contact Number : 087 0622429
QC Specialist required for Dublin based pharmaceutical multinational

Principal Responsibilities

Senior QC Associate – Investigations/Change Control 

We are seeking to recruit a Senior QC Associate to become a key member of the quality team within a well renowned Dublin based pharmaceutical multinational.

The successful candidate will lead, coordinate, contribute to and undertake activities pertaining to Quality Control Deviations, Corrective/ Preventive Actions, Analytical Results Assessments and Change Control records. 
The role provides technical expertise with a particular focus on Compliance and Continuous Improvement.

Key Responsibilities 

• All activities associated with QC Deviations, CAPA records, Analytical Results Assessments and Change Control. 
• Report writing for investigations. 
• Own and manage Change Controls through their life cycle for QC. 
• Lead, contribute to, oversee, run and participate in Root Cause Analysis, implementing improvements and Corrective Actions. 
• Trend analysis of Deviations relating to QC. 
• Ensure investigations constantly reflect current requirements and expectations. 
• Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings. 
• Ensure timely completion of QC Deviations, CAPAs and Change Controls utilizing the appropriate procedures and Quality Management Tracking System (QMTS). 
• Ensure timely completion of each stage of the Analytical Results Assessments in line with the Quality Control Out of Specification and Unexpected Results procedure(s). 
• Ensure flow of communication to stakeholders. 
• Develop and maintain quality systems within QC to ensure ongoing compliance with cGLP. 



Qualifications & Requirements

Qualifications and Experience: 
• Hold a third level qualification in a Science related discipline. 
• Minimum 4 years’ experience in a Biotechnology/ Pharmaceutical/ GMP Environment. 
• Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP. 
• Experience with Deviations and Laboratory investigations including CAPA identification and implementation. 
• Experience in leading Root Cause Analysis would be advantageous. 
• Experience in managing and owning Change Controls would be advantageous.

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



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