QA Specialist ( Equipment Introduction)

Berkley Group; Carlow; Hybrid; EUR 55,000 - 90,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Berkley Group in Carlow, Ireland, invites applications for a QA Specialist (Equipment & CQV) on an 11-month contract. The role provides quality oversight for introducing new equipment from commissioning through validation.

You will review engineering and qualification activities, support deviations, and participate in site compliance initiatives as part of a cross-functional quality team. The position offers hybrid working arrangements in a pharmaceutical manufacturing environment.

Qualifications

• 3–5 years of experience in a quality role in pharmaceutical manufacturing
• Experience with equipment validation (CQV) and process validation
• Strong cGMP/GDP knowledge and technical writing skills
• Familiarity with sterile filling processes

Responsibilities

• Quality review and approval of engineering, commissioning and qualification activities
• Quality review and approval of validation, automation and utilities activities
• QA oversight of change controls and quality risk assessments for new equipment
• Support deviation investigations and timely close-out
• Drive site compliance initiatives and participate in Plant/Quality committees

Skills

Quality review

CQV knowledge

Documentation

GMP knowledge

Risk assessments

Deviation investigations

Education

Science degree

Job description

QA Specialist (Equipment & CQV) Carlow 11-Month Contract

A pharmaceutical manufacturing company in Carlow is looking for a QA Specialist to provide quality oversight for the introduction of new equipment, from commissioning and qualification through to validation.

Key responsibilities:

• Quality review and approval of engineering, commissioning and qualification activities
• Quality review and approval of validation, automation and utilities activities
• QA oversight of change controls and Quality Risk Assessments for new equipment
• Support deviation investigations and timely close-out
• Drive site compliance initiatives and take part in Plant/Quality committees

Requirements:

• 3-5 years' experience in a quality role, ideally in pharmaceutical manufacturing
• Experience with equipment and process validation
• Familiarity with sterile filling processes and equipment
• cGMP/GDP knowledge and strong technical writing skills
• Science degree preferred; Lean Six Sigma desirable

Hybrid: 1-3 days per week onsite. Start date: ASAP.

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