Quality Assurance & Supplier Compliance Lead

Aphex Group; Carlow; Presencial; EUR 60 000 - 76 000; Tempo integral

Resumo da oferta

Aphex Group in Ireland (Carlow) seeks an experienced Quality Assurance professional to oversee supplier management, documentation, deviations, and compliance for pharma manufacturing. You will drive change controls, CAPAs, and cross-functional collaboration to ensure cGMP/GDP adherence.

The role emphasizes review of material packs, test specs, and supplier qualifications, with responsibility for technology transfer protocols and site-wide quality initiatives.

Qualificações

• 3–5 years of experience in a quality role, ideally in pharmaceutical manufacturing.
• Knowledge of regulatory/code requirements related to Irish, European, and international standards.
• Familiarity with cGMP and GDP is preferred.
• Strong report, standards and policy writing skills.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes and equipment is beneficial.
• Proficiency in Microsoft Office and related computer applications.
• Experience or familiarity with Lean Six Sigma methodology is desired.

Responsabilidades

• Supplier Management oversight
• Quality Agreement management & APR Quality Agreement Chapter owner
• Review documentation for new product/material introduction (Material Packs, QC Test Specifications, BOMs, Supplier Qualification, Oversight)
• Develop and monitor supplier performance metrics; participate in reviews and cross-functional forums
• Maintain approved supplier management list and ensure correct setup of suppliers and materials used at Carlow
• Support deviation and atypical closeout; initiate and follow up on CAPAs
• Support change controls & Supplier Complaints
• Provide quality oversight for new products/materials and manage external parties with re-evaluations
• Author, review, and approve protocols/reports for technology transfer, method qualification/validation
• Ensure site compliance with divisional policies, regulatory requirements; participate in Plant/Quality committees
• Act as functional expert in cross-functional team for product/material introductions at Carlow

Conhecimentos

Supplier Management

Quality Assurance

Regulatory Knowledge

cGMP

GDP

Documentation Skills

Process Validation

Lean Six Sigma

Team Collaboration

Independent Working

Decision Making

Problem Solving

MS Office

Descrição da oferta de emprego

Aphex Group in Ireland (Carlow) seeks an experienced Quality Assurance professional to oversee supplier management, documentation, deviations, and compliance for pharma manufacturing. You will drive change controls, CAPAs, and cross-functional collaboration to ensure cGMP/GDP adherence.

The role emphasizes review of material packs, test specs, and supplier qualifications, with responsibility for technology transfer protocols and site-wide quality initiatives.