QA Validation Specialist TPM6148

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

Summary:

Our client, a biopharmaceutical company located in Carlow, is seeking a QA Validation Specialist. The successful candidate will provide quality oversight for the introduction, commissioning, qualification and validation of new equipment, ensuring activities are completed in accordance with GMP and applicable regulatory requirements.

Responsibilities:

• Provide quality oversight and direction for the introduction of new equipment through commissioning, qualification and validation.
• Review and approve engineering, commissioning and qualification documentation and activities.
• Review and approve validation, automation and utilities documentation and activities.
• Support deviation investigations and ensure timely close-out.
• Provide quality oversight of change controls associated with the introduction, commissioning and qualification of new equipment.
• Provide quality oversight of quality risk assessments associated with the introduction, commissioning and qualification of new equipment.
• Provide compliance direction in line with site procedures, quality standards and applicable regulatory requirements.
• Evaluate site compliance against emerging regulatory and industry trends and support continuous-improvement initiatives.
• Participate in quality and site committees and collaborate effectively with cross-functional teams.

Qualifications & Experience:

• Bachelor's degree or higher in a related Science discipline is preferred.
• Minimum 3-5 years' experience in a quality role, ideally within a pharmaceutical or biopharmaceutical manufacturing environment.
• Experience with equipment and process validation, including commissioning and qualification activities.
• Knowledge of Irish, European and international regulatory requirements, codes, standards and industry practices.
• Working knowledge of cGMP and GDP requirements.
• Familiarity with sterile filling processes and equipment is an advantage.
• Strong report, standards, policy and technical-writing skills.
• Proficiency in Microsoft Office and relevant job-related computer applications.
• Lean Six Sigma knowledge or experience is desirable.