QA Specialist ( Equipment Introduction)

Berkley Group; Carlow; Presencial; EUR 60.000 - 75.000; Jornada completa

Descripción de la vacante

Berkley Group in Carlow is seeking a QA Specialist to provide quality oversight for the introduction of new equipment, from commissioning and qualification through to validation.

The role requires 3–5 years of QA experience in pharmaceutical manufacturing, strong validation familiarity, sterile filling knowledge, and robust technical writing skills. This is an 11-month contract based in Carlow, Ireland.

Formación

• 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.

Responsabilidades

• 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

Conocimientos

Quality oversight

Technical writing

GxP knowledge

CQV experience

Validation understanding

Descripción del empleo

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

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