Quality Assurance Specialist – Carlow

PE Global (UK); Carlow; On-site; EUR 42,000 - 52,000; Part time

Job summary

PE Global is seeking a QA Specialist for a 11-month hybrid contract in Carlow. The role focuses on QA oversight across analytical, warehouse and facilities management, with exposure to deviations, CAPAs and change controls.

You will review documentation for new product introductions and participate in supplier qualification and performance reviews. The ideal candidate has 3–5 years in a pharmaceutical quality role, knowledge of cGMP/GDP, and strong documentation skills.

Qualifications

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

Responsibilities

• Provide QA oversight to support analytical, warehouse and facilities management, incl deviations, root cause analysis, CAPAs and change controls.
• Act as a functional expert in the cross-functional team for introducing products and materials at Carlow.
• Review documentation for new product/material introductions (Material Packs, QC specs, BOMs, supplier qualification).
• Develop and monitor supplier performance metrics and participate in supplier reviews.
• Maintain the supplier management list in the QC system and ensure correct setup.
• Support deviation closure and corrective/preventive actions.
• Author and approve protocols/reports for technology transfer, method qualification/validation.
• Conduct quality reviews of engineering/validation/automation/utilities commissioning.
• Serve as site quality contact and coordinate quality working group meetings.
• Ensure compliance with divisional policies and regulatory requirements; drive site improvements.

Skills

QA Oversight

Documentation review

CAPA

Root cause analysis

Change controls

Supplier management

Quality audits

Regulatory knowledge

Analytical skills

MS Office

Education

Bachelor's degree in science

Tools

MS Office

Job description

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

11-month initial contract- hybrid

Role Description

Quality Assurance Specialist

Role Functions

• Provide QA oversight to support Analytical, Warehouse and Facilities Management, including deviations, Root cause analysis, CAPAs and change controls
• Participate as a functional expert in the cross-functional team responsible for introducing products and materials at Carlow.
• 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.
• Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties.
• Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
• Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
• Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
• 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.

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