QA Specialist TPM6124

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

Summary:

We currently have an opportunity for a QA Specialist to support a biopharmaceutical manufacturing site in Carlow. The successful candidate will provide quality oversight across supplier management, new product and material introduction, quality systems and site compliance activities.

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 associated with new product and material introduction, including material packs, QC test specifications, bills of materials and supplier documentation.
• Maintain approved supplier and material records within the relevant supplier management system.
• Support the investigation and closure of deviations and atypical results, including the initiation and follow-up of corrective and preventive actions.
• Support change controls, supplier complaints and material review board activities.
• Author, review and approve protocols and reports for technology transfer, method qualification and method validation.
• Provide quality and compliance guidance in line with site procedures, regulatory requirements and applicable quality standards.
• Assess emerging compliance trends and support continuous improvement initiatives across site quality systems.
• Participate as the QA representative on cross-functional teams supporting new products, materials and site quality initiatives.

Qualifications & Experience:

• Bachelor’s degree or higher in a related Science discipline.
• Minimum 3-5 years’ experience in a quality role, ideally within a pharmaceutical manufacturing environment.
• Good knowledge of Irish, European and international regulatory requirements, codes and industry practices.
• Working knowledge of cGMP and GDP requirements.
• Experience in supplier quality management, quality systems, equipment or process validation and deviation/CAPA management.
• Experience with sterile filling processes and equipment is an advantage.
• Strong technical writing skills, with experience preparing reports, standards, policies, protocols and quality documentation.
• Proficiency in Microsoft Office and relevant quality or business systems.
• Lean Six Sigma knowledge or experience is an advantage.