Quality Assurance Chemist: GxP & Compliance Expert

Pfizer; Ringaskiddy; On-site; EUR 45,000 - 65,000; Full time

Job summary

Pfizer in Ireland is seeking a Quality Assurance professional to evaluate clinical and commercial drug batches, ensure cGMP compliance, and oversee site documentation. The role emphasizes risk-based quality culture and collaboration across teams in a patient-centric environment.

The position requires strong understanding of GxP, proficiency with MS Excel/Word, and experience with investigations, change control, and regulatory standards.

Qualifications

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience.
• Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards.
• Proactive approach to problem-solving and good working knowledge of MS Office.

Responsibilities

• Evaluate and review clinical and commercial drug batches to ensure compliance with specifications.
• Conduct sampling and statistical process control to identify deviations.
• Approve investigations and change control activities to maintain GxP compliance.
• Contribute to moderately complex projects and develop short-term work plans.
• Independently assess Change Control activities for GxP impacts.
• Investigate and document QA deviations and escalate as needed.
• Ensure regulatory compliance and provide QA oversight of site documentation.

Skills

Critical thinking

Team collaboration

Problem solving

Quality mindset

Education

High school diploma + 8+ years

Associate's degree + 6+ years

BA/BS + 2+ years

MBA/MS + relevant exp

Tools

Microsoft Excel

Microsoft Word

Job description

Pfizer in Ireland is seeking a Quality Assurance professional to evaluate clinical and commercial drug batches, ensure cGMP compliance, and oversee site documentation. The role emphasizes risk-based quality culture and collaboration across teams in a patient-centric environment.

The position requires strong understanding of GxP, proficiency with MS Excel/Word, and experience with investigations, change control, and regulatory standards.