Pharma QA Specialist - Validation & Compliance (Ireland)

PSC Biotech Corporation; Carlow; Hybrid; EUR 65,000 - 95,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks a Quality Assurance professional with 3-5 years of experience in pharmaceutical quality roles. You will oversee equipment introduction, validation activities, and quality reviews across engineering and commissioning to support top pharmaceutical client sites.

This role emphasizes regulatory compliance, cGMP/GDP familiarity, and collaboration. You’ll contribute to continuous improvement through Lean Six Sigma, risk assessments, and timely deviation

Qualifications

• 3-5 years of experience in a quality role, ideally pharma manufacturing.
• 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 report, standards, and 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 the ability to work effectively as part of a team to determine priorities.
• Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
• Proven ability to drive the completion of tasks.
• Strong decision-making capability with a sense of accountability and responsibility.
• Demonstrated problem-solving skills.

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 activities

Regulatory understanding

cGMP/GDP knowledge

Lean Six Sigma

Collaboration

Independent ownership

Decision making

Problem solving

Education

Bachelor's degree or higher in related science

Job description

PSC Biotech Corporation in Ireland seeks a Quality Assurance professional with 3-5 years of experience in pharmaceutical quality roles. You will oversee equipment introduction, validation activities, and quality reviews across engineering and commissioning to support top pharmaceutical client sites.

This role emphasizes regulatory compliance, cGMP/GDP familiarity, and collaboration. You’ll contribute to continuous improvement through Lean Six Sigma, risk assessments, and timely deviation