QA Validation Lead: Equipment & Compliance

Tandem Project Management Ltd.; Carlow; A distancia; EUR 55.000 - 75.000; Jornada completa

Descripción de la vacante

Tandem Project Management Ltd. in Ireland seeks a QA Validation Specialist to oversee the introduction, commissioning, qualification and validation of new equipment in a GMP environment. The role requires strong knowledge of cGMP, GDP, and regulatory requirements, with 3–5 years in a quality-focused pharmaceutical setting.

Collaboration with engineering, manufacturing and QA teams will be essential. Experience with sterile filling processes is advantageous, and strong technical writing,

Formación

• Bachelor's degree in a related science discipline is preferred.
• 3–5 years' experience in a quality role in pharma/biopharma manufacturing.

Responsabilidades

• Provide quality oversight for the introduction, commissioning, qualification and validation of new equipment.
• Review and approve engineering, commissioning, qualification, and validation documentation.
• Review and approve validation, automation and utilities documentation and activities.
• Support deviation investigations and ensure timely close-out.
• Quality oversight of change controls for new equipment.

Conocimientos

Quality assurance

GMP knowledge

Documentation

Cross-functional collaboration

Regulatory knowledge

Educación

Bachelor's degree in a related Science discipline

Herramientas

MS Office

Descripción del empleo

Tandem Project Management Ltd. in Ireland seeks a QA Validation Specialist to oversee the introduction, commissioning, qualification and validation of new equipment in a GMP environment. The role requires strong knowledge of cGMP, GDP, and regulatory requirements, with 3–5 years in a quality-focused pharmaceutical setting.

Collaboration with engineering, manufacturing and QA teams will be essential. Experience with sterile filling processes is advantageous, and strong technical writing,