Job Description

Shape Quality Excellence Across Pharmaceutical Manufacturing

Quality Assurance Specialist

Imagine joining a quality team where your expertise helps ensure every product, process, supplier, and system meets the highest standards of compliance before reaching patients. In this role, you'll provide quality oversight across manufacturing support functions, supplier management, validation activities, and new product introductions, helping to maintain operational excellence within a highly regulated pharmaceutical environment.

This opportunity is ideal for a Quality Assurance professional who enjoys working across multiple disciplines, solving quality challenges, and driving continuous improvement while ensuring compliance with global GMP standards.

What you'll achieve (and why it matters)

Bring your quality expertise into a modern pharmaceutical manufacturing environment where compliance, collaboration, and patient safety are at the heart of every decision:

• Provide Quality Assurance oversight across Analytical Laboratories, Warehouse Operations, and Facilities Management

• Review and support deviations, root cause investigations, CAPAs, and change control activities

• Participate in cross-functional teams responsible for introducing new products and materials into manufacturing

• Review and approve quality documentation, including Material Packs, Bills of Materials, QC Test Specifications, supplier qualification documentation, and technology transfer records

• Support supplier quality management by maintaining approved supplier records, monitoring supplier performance, and participating in supplier reviews

• Author, review, and approve protocols and reports relating to technology transfer, method qualification, method validation, commissioning, and equipment qualification

• Conduct quality reviews of engineering, validation, automation, and utilities documentation to ensure regulatory compliance

• Participate in quality audits and inspections, identifying opportunities for improvement and supporting corrective actions

• Collaborate with Manufacturing, Engineering, Validation, Supply Chain, Laboratory, and Quality teams to ensure ongoing GMP compliance

• Help maintain inspection readiness by supporting site quality initiatives and regulatory compliance activities

• Contribute to continuous improvement projects that strengthen quality systems and operational performance

Your edge (desired, not required)

• 3–5 years' experience in a Quality Assurance role within the pharmaceutical, biotechnology, chemical, or other highly regulated manufacturing industry

• Strong knowledge of cGMP requirements and pharmaceutical quality systems

• Experience managing deviations, investigations, CAPAs, and change controls

• Knowledge of supplier quality management and new product introduction activities

• Experience reviewing validation, qualification, and technology transfer documentation

• Familiarity with equipment and process validation within GMP environments

• Strong technical writing, documentation review, and report writing skills

• Excellent communication and stakeholder management abilities

• Strong problem-solving skills with the ability to work independently while collaborating across multiple functions

• Bachelor's degree or higher in a Science, Engineering, Pharmaceutical, Biotechnology, or related discipline

Why this role matters

You'll play an important role in ensuring products, materials, suppliers, and manufacturing processes consistently meet the highest standards of quality and regulatory compliance. Working alongside experienced technical and operational teams, you'll gain exposure to product introductions, supplier quality, validation, compliance initiatives, and pharmaceutical manufacturing while helping deliver medicines safely and efficiently.

The next step for you

If this opportunity is of interest, please send your CV to danielle.johnson@nextgeneration.ie or apply through our website.

All applications are treated in the strictest confidence.

Next Generation Recruitment specializes in Engineering, Quality, Technical, Supply Chain, Manufacturing, Scientific, and Operations roles across permanent, contract, and temporary appointments.

Your data will never be shared outside our organisation without your prior written consent.