QC Analyst

Cpl Group; Dublin; On-site; EUR 40,000 - 60,000; Full time

Job summary

Cpl Group in Ireland is seeking a QC Analyst to support initiation, writing, review and execution of laboratory investigations within a GMP QC environment.

The role focuses on investigative deviations, invalid results and LIRs, applying structured root cause analysis and ensuring documentation meets regulatory standards. Collaboration across QC, QA and Manufacturing is essential.

Qualifications

• 1–2 years' experience in a GMP QC lab or similar
• Proficient with HPLC, GC, autotitrators and wet chemistry
• Experience initiating and writing Invalids and LIRs
• Experience with LIMS and TrackWise or similar electronic quality system
• Strong planning, organisational and problem-solving skills

Responsibilities

• Initiate and write Invalids and Laboratory Investigation Reports (LIRs).
• Review and approve laboratory investigation documentation in line with GMP requirements.
• Perform root cause analysis using Fishbone diagrams and 5 Whys.
• Support analytical testing using HPLC, GC, autotitrators, and wet chemistry techniques.
• Work cross-functionally with QC, QA, and Manufacturing to gather investigation data.
• Ensure investigations and documentation are completed accurately and within timelines.
• Utilise TrackWise or similar electronic quality systems to manage investigations and deviations.
• Use LIMS to review laboratory data and support investigation activities.
• Contribute to continuous improvement initiatives within the QC laboratory.

Skills

GMP knowledge

Lab investigations

Root cause analysis

Communication

Tools

HPLC

GC

Autotitrators

LIMS

TrackWise

Job description

Company Profile

Our client is a well-established pharmaceutical manufacturer specialising in generic medicines, supplying regulated markets across Europe and North America. The site focuses on Oral Solid Dose (OSD) manufacturing, supported by modern facilities, strong GMP quality systems, and a culture of continuous improvement.

Job Summary

The QC Analyst will support the initiation, writing, review, and execution of laboratory investigations within a GMP QC environment. The role will focus on investigating analytical deviations, invalid results, and Laboratory Investigation Reports (LIRs) while applying structured root cause analysis and ensuring documentation meets regulatory and quality standards.

Key Responsibilities

• Initiate and write Invalids and Laboratory Investigation Reports (LIRs).
• Support the review and approval of laboratory investigation documentation in line with GMP requirements.
• Perform root cause analysis using tools such as Fishbone diagrams and 5 Whys.
• Support analytical testing using HPLC, GC, autotitrators, and wet chemistry techniques where required.
• Work cross-functionally with QC, QA, and Manufacturing teams to gather investigation data.
• Ensure investigations and documentation are completed accurately and within required timelines.
• Utilise TrackWise or similar electronic quality systems to manage investigations and deviations.
• Use LIMS to review laboratory data and support investigation activities.
• Contribute to continuous improvement initiatives within the QC laboratory.

Candidate Requirements

• 1-2years’ experience in a QC laboratory or similar GMP-regulated environment.
• Good working knowledge of HPLC, GC, autotitrators, and wet chemistry techniques.
• Experience initiating and writing Invalids and Laboratory Investigation Reports (LIRs).
• Previous experience working with LIMS.
• Experience using TrackWise or a similar electronic quality system.
• Strong planning, organisational, and problem-solving skills.
• Excellent communication and interpersonal skills.
• Microbiological experience would be a strong advantage.