NPI Quality Assurance Specialist: Transfers & Compliance

Sigmar Recruitment; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

Sigmar Recruitment is seeking a Senior NPI Compliance Specialist for a pharmaceutical manufacturing client in North Dublin on a 12-month contract. You will drive QA processes, ensure regulatory alignment, and support transfers from development through commercialization.

You will liaise with cross-functional teams, manage method transfers/validation, vendor agreements, and document quality milestones, with a focus on risk mitigation and site compliance.

Qualifications

• Third level qualification in a science discipline.
• 5 years' experience in the healthcare / pharmaceutical industry.
• A minimum of 3 years experience in a Quality role.
• Being QP eligible is desirable.

Responsibilities

• Implement and maintain integration of projects and NPI into the quality system.
• Ensure regulatory requirements and company procedures are met.
• Support transfers from development to commercialization for NPIs.
• Review and approve NPI analytical method transfers/validation.
• Support vendor evaluation and management of technical agreements.
• Collaborate with local and site functions to identify quality issues and provide mitigation.
• Coordinate site review of material specifications (API, drug product, excipients).
• Generate corrective/preventative actions for new projects and exceptions.
• Prepare quality project documentation for project stage reviews.
• Act as Quality SME for new projects/NPIs and coordinate site QA reviews.

Skills

Quality systems

Regulatory compliance

NPI compliance

Cross-functional collaboration

Audits support

Project coordination

Risk mitigation

Education

Bachelor's degree in a science discipline

Job description

Sigmar Recruitment is seeking a Senior NPI Compliance Specialist for a pharmaceutical manufacturing client in North Dublin on a 12-month contract. You will drive QA processes, ensure regulatory alignment, and support transfers from development through commercialization.

You will liaise with cross-functional teams, manage method transfers/validation, vendor agreements, and document quality milestones, with a focus on risk mitigation and site compliance.