QA Specialist: Biopharma Quality & Compliance Lead

Tandem Project Management Ltd.; Carlow; On-site; EUR 55,000 - 75,000; Full time

Job summary

Tandem Project Management Ltd. seeks a QA Specialist to support a biopharmaceutical manufacturing site in Carlow. The role provides quality oversight across supplier management, new product introduction, quality systems and site compliance.

You will participate in deviation/CAPA investigations, change controls, and supplier documentation. Strong regulatory knowledge and technical writing are essential for success in this role.

Qualifications

• Bachelor’s degree or higher in a related Science discipline.
• 3-5 years in a quality role, ideally pharma manufacturing.
• Understanding of Irish, European and international regulatory requirements.
• Working knowledge of cGMP and GDP.
• Experience with supplier quality management and CAPA.
• Experience with sterile filling is an advantage.
• Strong technical writing for reports and quality docs.
• Proficiency in Microsoft Office and quality systems.

Responsibilities

• Provide quality oversight for supplier management activities, including supplier qualification, performance monitoring and periodic re-evaluation.
• Manage Quality Agreements and support the Annual Product Review Quality Agreement chapter.
• Review and approve documentation for new product and material introduction, including packs, QC specs, BOMs and supplier docs.
• Maintain approved supplier/material records in the supplier management system.
• Support deviations, CAPA, and investigations; assist with change controls and material reviews.
• Lead QA input on tech transfer, method qualification/validation protocols and reports.
• Provide quality guidance aligned with site procedures and regulatory requirements.
• Identify emerging compliance trends and support site quality improvements.
• Participate as QA representative on cross-functional teams for new products and site quality initiatives.

Skills

Quality management

Documentation

Regulatory knowledge

CAPA/Deviation handling

Supplier quality management

Process validation

cGMP knowledge

GDP knowledge

Technical writing

MS Office

Lean Six Sigma (adv)

Education

Bachelor’s degree in a related Science discipline

Tools

MS Excel

Quality systems software

Job description

Tandem Project Management Ltd. seeks a QA Specialist to support a biopharmaceutical manufacturing site in Carlow. The role provides quality oversight across supplier management, new product introduction, quality systems and site compliance.

You will participate in deviation/CAPA investigations, change controls, and supplier documentation. Strong regulatory knowledge and technical writing are essential for success in this role.