Quality Assurance Specialist – Pharma/Biotech Validation

PSC Biotech® Corporation; Carlow; On-site; EUR 65,000 - 90,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks a Quality Assurance professional to provide oversight across equipment introduction, validation and change control. The role focuses on ensuring compliance with cGMP and GDP, reviewing engineering and commissioning activities, and guiding deviation investigations to closure.

Ideal candidates have 3–5 years in a pharmaceutical quality role, a related science degree, and a mindset for continuous improvement.

Qualifications

• A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
• A Bachelor's degree or higher in a related Science discipline is preferred.
• Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
• Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
• Strong Continuous Improvement Mindset and reporting/policy writing skills.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications.
• Experience or familiarity with Lean Six Sigma methodology is desired.
• Good collaboration skills and ability to work independently.

Responsibilities

• Provide quality oversight and direction for the introduction of new equipment up to and including validation activities.
• Conduct quality reviews and approvals of engineering/ commissioning and qualification activities.
• Conduct quality reviews and approvals of validation/automation/utilities activities.
• Support deviation Investigations and close out in a timely manner.
• Quality oversite of Change controls related to introduction, commissioning and qualification of new equipment.
• Quality oversite of Quality Risk assessments related to introduction, commissioning and qualification of new equipment.
• Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements.
• Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency.
• Actively participate in Plant/Quality committees and collaborate with other site functional groups.

Skills

Quality oversight

Validation experience

Regulatory compliance

cGMP/GDP

Lean Six Sigma

Microsoft Office

Team collaboration

Independent initiative

Problem solving

Decision making

Education

Bachelor's degree or higher in a related Science discipline

11 Month of Contract

Job description

PSC Biotech Corporation in Ireland seeks a Quality Assurance professional to provide oversight across equipment introduction, validation and change control. The role focuses on ensuring compliance with cGMP and GDP, reviewing engineering and commissioning activities, and guiding deviation investigations to closure.

Ideal candidates have 3–5 years in a pharmaceutical quality role, a related science degree, and a mindset for continuous improvement.