Quality Assurance Specialist

Life Science Recruitment; Leinster; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

Life Science Recruitment is seeking a QA Specialist for an award-winning pharmaceutical organization based in Carlow. This is a 11-month contract with hybrid work and daily in-office presence in Carlow.

The role covers supplier management oversight, quality agreements, and documentation validation for new products and materials. A scientific degree and 3–5 years in quality are preferred, with cGMP/GDP knowledge.

Qualifications

• Bachelor's degree or higher in a related Science discipline.
• 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
• 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.

Responsibilities

• Supplier management oversight and APR Quality Agreement ownership.
• Review documentation for new product/material introduction (Packs, specs, BOMs, supplier qualification).
• Develop and monitor supplier performance metrics and participate in supplier reviews.
• Maintain the approved supplier management list for Carlow site.
• Support deviation, CAPA, change controls, and supplier complaints.
• Provide quality oversight for technology transfer, method qualification and validation.
• Ensure site compliance with divisional policies and regulatory requirements.
• Participate in cross-functional teams for product introductions.

Skills

Quality management

Regulatory understanding

Documentation skills

Cross-functional collaboration

Education

Bachelor's degree in Science

Job description

QA Specialist

Days & hybrid

RK26520

Contract 11 months

Carlow

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Key Responsibilities:

• Supplier Management oversight
• Quality Agreement management & APR Quality Agreement Chapter owner
• Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, Supplier Qualification and Oversight.
• Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers, and actively engage in cross-functional forums as needed.
• Maintain the approved supplier management list within the qualified Supplier Management system, ensuring correct setup of suppliers and materials used at Carlow.
• Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions.
• Support change controls & Supplier Complaints.
• Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties including periodic re-evaluations.
• Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
• 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.
• Participate as a functional expert in the cross-functional team responsible for introducing products and materials.

Education and Experience:

• A Bachelor's degree or higher in a related Science discipline is preferred.
• A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
• 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.