Supplier Quality Specialist

PE Global; Carlow; On-site; EUR 50,000 - 70,000; Full time

Job summary

PE Global is seeking a QA Specialist – Supplier for an 11-month hybrid contract based in Carlow, Ireland. The role focuses on supplier quality agreements, APR ownership, and oversight of supplier documentation, deviations and change controls.

You will review materials for new product introductions, monitor supplier performance, and drive corrective actions while collaborating across cross-functional teams and quality committees to ensure compliance and continuous improvement.

Qualifications

• 3–5 years in a quality role in a pharmaceutical manufacturing environment.
• Knowledge of Irish, European and international codes, standards and practices.
• Familiarity with cGMP and GDP is preferred.
• Strong report, standards and policy writing skills.
• Experience with equipment and process validation.

Responsibilities

• Quality agreement creation/management and APR chapter owner.
• Review documentation for new product/material introduction (Material Packs, QC Test Specifications, BOMs, Supplier Qualification).
• Develop and monitor supplier performance metrics; participate in supplier reviews.
• Support deviations, atypical closeout, CAPAs and change controls.
• Provide quality oversight for introduction of new products/materials; manage external parties.
• Author/review/approve protocols and reports for technology transfer, method qualification/validation.
• Ensure site compliance with regulatory requirements and participate in quality committee activities.
• Collaborate with cross-functional teams during product/material introductions.

Skills

Supplier management

Quality agreements

Regulatory compliance

CAPA & deviation handling

Documentation review

Process validation familiarity

Cross-functional collaboration

Lean Six Sigma familiarity

Microsoft Office

Education

Bachelor’s degree in science

Tools

GMP knowledge

Job description

PE Global is currently recruiting a QA Specialist – Supplier on behalf of our client based in Carlow:

11-month initial contract- hybrid

* Quality agreement creation/management/APR chapter owner drafting, management of approved supplier list, change controls, supplier complaints, deviations*

Role Functions

(Functions include, but are not limited to, the following)

• 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 at Carlow.

Experience, Knowledge & Skills

• 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.
• 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

Qualifications & Education

• A Bachelor’s degree or higher in a related Science discipline is preferred.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***