QA CQV Specialist: Validation & Compliance Leader

Tandem Project Management Limited; Leinster; On-site; EUR 55,000 - 75,000; Full time

Job summary

A project management firm based in Ireland is seeking a QA CQV Specialist to provide quality oversight of validation activities. The ideal candidate will have a B.Sc or B.Eng in a scientific or engineering discipline and 4 to 5 years of experience in quality assurance within regulated manufacturing environments. Responsibilities include overseeing validation processes, reviewing documentation, and ensuring compliance with regulatory requirements. This position offers a unique opportunity to contribute to quality assurance in a dynamic environment.

Qualifications

• 4 to 5 years of experience in Quality Engineering or Assurance in regulated environments.
• Strong understanding of cGMP regulations.
• Excellent knowledge of GxP regulations applicable to biologics manufacturing.

Responsibilities

• Ensure quality oversight of validation activities.
• Review and approve validation documentation.
• Provide QA oversight for deviations and investigations.
• Support regulatory inspections and client audits.
• Coordinate QA validation activities.

Skills

Quality Engineering

Quality Assurance

Quality Validation

Regulatory Compliance

Root Cause Analysis

Education

B.Sc or B.Eng in a Scientific or Engineering discipline

Tools

Ishikawa diagrams

FMEA

Job description

A project management firm based in Ireland is seeking a QA CQV Specialist to provide quality oversight of validation activities. The ideal candidate will have a B.Sc or B.Eng in a scientific or engineering discipline and 4 to 5 years of experience in quality assurance within regulated manufacturing environments. Responsibilities include overseeing validation processes, reviewing documentation, and ensuring compliance with regulatory requirements. This position offers a unique opportunity to contribute to quality assurance in a dynamic environment.