QC Instrumentation Specialist – GMP Lab Systems

PE Global

Leinster

On-site

EUR 60,000 - 80,000

Full time

4 days ago
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Job summary

PE Global is recruiting a QC Instrumentation Associate for our pharmaceutical industry client in Carlow. This is an initial 11-month contract, onsite role.

The candidate will drive GMP/cGMP and cGLP compliance, oversee external vendors for calibration and qualification activities, and lead continuous improvement initiatives within a GMP environment. Responsibilities include supporting audits, coordinating testing/validation, and ensuring timely execution of instrumentation projects.

Qualifications

  • Bachelor's degree or higher in Chemistry/Science or closely related discipline.
  • Considerable experience in GMP settings with cGMP and GDP knowledge preferred.
  • Experience with data integrity and regulatory compliance.
  • Lean Six Sigma experience desired.

Responsibilities

  • Ensure compliance with cGMP, cGLP and regulatory requirements in day-to-day activities and testing.
  • Provide technical oversight for calibration PM/OQ activities on laboratory instruments.
  • Lead day-to-day oversight of external vendors and coordination of instrumentation projects.
  • Facilitate communication across lab systems, instrumentation and support functions to keep testing and validation on schedule.
  • Represent QC on site and cross-functional projects; support audit/inspection readiness.
  • Drive continuous improvement using RCA tools like FMEA and 5 Whys.

Skills

GMP compliance
cGMP
cGLP
Data integrity
Root cause analysis
FMEA / 5 whys
Leadership
Audit readiness
Microsoft Office

Education

Bachelor's degree in Chemistry/Science

Tools

Microsoft Office

Job description

PE Global is recruiting a QC Instrumentation Associate for our pharmaceutical industry client in Carlow. This is an initial 11-month contract, onsite role.

The candidate will drive GMP/cGMP and cGLP compliance, oversee external vendors for calibration and qualification activities, and lead continuous improvement initiatives within a GMP environment. Responsibilities include supporting audits, coordinating testing/validation, and ensuring timely execution of instrumentation projects.

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