QC Analyst – GMP Lab for High-Value Pharmaceuticals

R&D Partners; Munster; On-site; EUR 35,000 - 55,000; Full time

Job summary

R&D Partners seeks a capable QC laboratory professional to join its state-of-the-art facility in Ireland. You will perform routine analytical testing, support method validation and transfers, and help maintain compliant documentation under cGMP and SOP standards.

Collaboration with manufacturing and engineering teams is essential to ensure product quality. You will contribute to regulatory inspection readiness, CAPA investigations, and root cause analyses while upholding GDP and Good

Qualifications

• Experience performing analytical testing in a regulated laboratory.
• Strong data review and documentation practices.
• Familiarity with cGMP, SOPs, and regulatory requirements.

Responsibilities

• Perform routine laboratory testing, investigations, and data review in compliance with SOPs, cGMP standards, and regulatory requirements.
• Support analytical method verification, validation, and technology transfer activities to ensure robust testing processes.
• Prepare, review, and maintain laboratory documentation, including procedures, specifications, protocols, reports, and testing records.
• Assist with laboratory operations, including equipment qualification, calibration activities, consumables management, and laboratory setup.
• Contribute to regulatory inspection readiness by supporting audits, compliance initiatives, and quality management system requirements.
• Collaborate cross-functionally with manufacturing, engineering, warehouse, and other internal teams to support operational and quality objectives.
• Promote a safe, organised, and compliant laboratory environment while ensuring all training, documentation, and quality standards are consistently maintained.
• Pharmaceutical or biotechnology QC laboratory
• Knowledge of analytical instrumentation (e.g., HPLC, GC, analytical balances, or equivalent platforms)
• Proven experience performing analytical testing in line with SOPs, cGMP, and regulatory requirements
• Hands-on experience with method validation, verification, or technical transfer activities
• Strong background in data review and Good Documentation Practice (GDP)
• Demonstrated experience supporting deviation investigations, CAPA, and root cause analysis
• Previous involvement in regulatory inspections, audits, or audit readiness activities

Skills

Analytical testing

Data review

GDP (Good Documentation Practice)

cGMP compliance

Method validation/verification

CAPA & root cause analysis

Regulatory inspections readiness

Tools

HPLC

GC

Analytical balances

Instrumentation qualification

Job description

R&D Partners seeks a capable QC laboratory professional to join its state-of-the-art facility in Ireland. You will perform routine analytical testing, support method validation and transfers, and help maintain compliant documentation under cGMP and SOP standards.

Collaboration with manufacturing and engineering teams is essential to ensure product quality. You will contribute to regulatory inspection readiness, CAPA investigations, and root cause analyses while upholding GDP and Good