QC Validation Specialist

FRS Recruitment ·www.frsrecruitment.com

Location Limerick, Limerick, Ireland
Salary EUR 60,000 - 65,000 / year
Type Full time
Level Mid
Source Shazamme
Pharmaceutical & Medical Device
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Seeking a QC Validation Specialist !

This position plays a critical role in ensuring analytical methods are properly designed, validated and transferred in alignment with EU/FDA GMP requirements for advanced therapy products.

We are particularly interested in speaking with candidates who have hands-on experience designing validation studies, as well as authoring and reviewing validation protocols and reports—not just executing test methods developed by others. A genuine understanding of the regulatory landscape and the rationale behind validation activities is essential.

The Role

In this position, you will:

  • Lead and support the development, validation and technology transfer of new and established analytical methods for gene therapy products.

  • Design validation studies and generate validation protocols, data analysis summaries and comprehensive reports.

  • Ensure analytical methods are fully validated and transferred into QC GMP laboratories in line with regulatory expectations (EU/FDA, ICH Q2(R1), GMP, data integrity).

  • Create, update and maintain method SOPs and technical documentation.

  • Provide clear communication and progress updates to cross-functional stakeholders.

  • Conduct routine assessments of analytical methods to ensure continued control and suitability.

  • Support Quality Management System activities, including document control and data integrity oversight.

  • Maintain and track personal training, GMP compliance and document lifecycle responsibilities (deviations, CAPAs, change controls).

  • When required, perform analytical testing of gene therapy products according to approved specifications.

Candidate Profile

  • A degree or Master’s in a scientific discipline (e.g., Biology, Biotechnology, Biochemistry).

  • Approx. 2+ years’ experience in the pharmaceutical, biologics, or a similarly regulated environment.

  • Demonstrated experience in method validation, including:

    • Designing validation studies,

    • Writing and reviewing protocols and validation reports,

    • A strong understanding of regulatory requirements and data integrity.

  • Experience with analytical techniques (advantageous but not essential): qPCR, HPLC (RP-HPLC/SEC), ELISA, SDS-PAGE/Western blot, cell culture, DNA extraction.

  • Strong understanding of ICH Q2(R1).

  • Proficiency in Microsoft Office (Word, Excel, PowerPoint).

Keywords: QC Validation Chemist, Method Transfer Chemist, Analytical Chemist, Scientist, Chemist, Analytical Chemist, Scientist,Chemist, HPLC,GMP

Frequently asked questions

Who is hiring for the QC Validation Specialist role?
FRS Recruitment is hiring for the QC Validation Specialist position, a Shazamme client. Apply directly on the employer's career site.
Where is the QC Validation Specialist job located?
The QC Validation Specialist role with FRS Recruitment is based in Limerick, IE.
What does the QC Validation Specialist role pay?
FRS Recruitment lists the QC Validation Specialist role at EUR 60,000–65,000 per year.
Is the QC Validation Specialist role full-time or contract?
This is a full time position at FRS Recruitment.
What experience level is the QC Validation Specialist role?
The QC Validation Specialist position is aimed at mid-level candidates.
How do I apply for the QC Validation Specialist role at FRS Recruitment?
Apply directly on FRS Recruitment's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.
Apply direct