CPV Quality Quality Support

EFOR; Munster; On-site; EUR 42,000 - 64,000; Full time

Job summary

EFOR Group is hiring a QC Data Remediation Specialist to join a global pharmaceutical manufacturer in Waterford. The role focuses on Continued Process Verification (CPV) to ensure QC results are complete, correct, traceable and ready to trend.

Key tasks include mapping CPV data needs, reconciling LIMS data, aligning master data, applying data integrity controls, and generating CPV status reports while collaborating with QC, QA and MSAT teams.

Qualifications

• Degree in Chemistry, Biochemistry, Microbiology, Pharmacy or similar.
• 3-6 years in GMP QC, QA or laboratory systems at a pharmaceutical site.
• Hands-on LIMS experience (e.g. LabWare, LabVantage, STARLIMS) and a good understanding of laboratory data flows.

Responsibilities

• List the QC data each product's CPV plan needs: release, in-process and stability results.
• Compare source records with LIMS and other lab data systems, then fix missing or inconsistent results.
• Support master data alignment: specifications, test methods, units and limits.
• Apply data integrity controls and document the rationale and traceability for every fix.
• Produce data-quality status reports for the CPV programme.
• Work with QC lab leads, QA and MSAT to agree what each product needs, and close the gaps.

Skills

LIMS

Data integrity

Excel

SQL

Power BI

QA

Education

Bachelor's degree in Life Sciences

Tools

LabWare

LabVantage

STARLIMS

Power BI

SQL

Job description

Now Hiring: CPV Quality Support - QC Data Remediation (Waterford, Ireland | Onsite)

Did you start out as a QC analyst and end up as the person everyone asks about LIMS? EFOR Group, a trusted Life Sciences consulting partner, is looking for a QC Data Remediation Specialist to join a global pharmaceutical manufacturer in Waterford. The role is part of a network-wide Continued Process Verification (CPV) programme. Your mission: make the site's QC results complete, correct, traceable and ready to trend.

What you'll do:

• List the QC data each product's CPV plan needs: release, in-process and stability results
• Compare source records with LIMS and other lab data systems, then fix missing or inconsistent results
• Support master data alignment: specifications, test methods, units and limits
• Apply data integrity controls and document the rationale and traceability for every fix
• Produce data-quality status reports for the CPV programme
• Work with QC lab leads, QA and MSAT to agree what each product needs, and close the gaps

Your background:

• Degree in Chemistry, Biochemistry, Microbiology, Pharmacy or similar
• 3-6 years in GMP QC, QA or laboratory systems at a pharmaceutical site
• Hands-on LIMS experience (e.g. LabWare, LabVantage, STARLIMS) and a good understanding of laboratory data flows
• Strong knowledge of data integrity (ALCOA+), EU GMP Annex 11 and 21 CFR Part 11
• Good understanding of QC analytical methods and specifications, plus strong Excel skills
• LIMS data migration, data remediation or LIMS implementation experience is strongly preferred; SQL or Power BI is a plus
• Rigorous, an excellent documenter, and comfortable working through large datasets on your own

Why EFOR Group?

EFOR brings together more than 3,200 experts in 18 countries, delivering technical, quality and engineering excellence across the full Life Sciences product lifecycle. Join a team helping to build trusted lab data that underpins the quality of medicines.

Location:

Waterford, Ireland (onsite)