Quality Assurance Specialist

Independent Solutions; Carlow; Hybrid; EUR 65,000 - 95,000; Full time

Job summary

Independent Solutions in Ireland (Carlow) is seeking a Quality Assurance Specialist for a hybrid role (1–3 days onsite weekly). Start date ASAP. The role focuses on supplier quality management, quality agreements, and compliance activities in a regulated pharmaceutical environment.

You will review supplier qualifications, manage supplier documentation, and support deviations, CAPAs, and change controls through to closure, ensuring alignment with GMP standards and site requirements.

Qualifications

• Degree in Science or related discipline.
• Minimum 5 years in a QA role within pharma or regulated manufacturing.
• Strong supplier quality management and quality agreements experience.
• Solid knowledge of GMP, GDP, deviations, CAPAs and change controls.

Responsibilities

• Manage supplier qualification, oversight, and Approved Supplier List activities.
• Maintain Quality Agreements and support APR Quality Agreement chapters.
• Review quality documentation for new products and materials.
• Monitor supplier performance and participate in supplier reviews.
• Support deviations, CAPAs, supplier complaints, and change controls to closure.
• Provide quality oversight for new product and material introductions.
• Author/review/approve protocols and reports for technology transfer and validation.
• Ensure compliance with GMP, regulatory requirements and site standards.
• Collaborate with cross-functional teams on quality initiatives.

Skills

Communication skills

Problem-solving

Technical writing

Education

Bachelor’s degree in Science/Pharmaceutical/related discipline

Tools

Microsoft Office

Job description

Job Title: Quality Assurance Specialist

Location: Carlow, Ireland (Hybrid – 1 to 3 days onsite per week)

Contract: Contract

Start Date: ASAP

Overview

An excellent opportunity for an experienced Quality Assurance Specialist to join a regulated pharmaceutical manufacturing environment. The role will focus on Supplier Quality Management, Quality Agreements, supplier qualification, compliance activities, and support for new product and material introductions.

Key Responsibilities

• Manage supplier qualification, supplier oversight, and Approved Supplier List activities.
• Maintain Quality Agreements and support Annual Product Review (APR) Quality Agreement chapters.
• Review quality documentation related to new products and materials, including supplier qualification packages, material specifications, and BOMs.
• Monitor supplier performance and participate in supplier reviews and cross-functional meetings.
• Support deviations, CAPAs, supplier complaints, and change controls through to closure.
• Provide quality oversight for new product and material introductions.
• Author, review, and approve protocols and reports related to technology transfer, method qualification, and validation activities.
• Ensure compliance with GMP, regulatory requirements, and site quality standards.
• Collaborate with cross-functional teams to support quality and compliance initiatives.

Requirements

• Degree in Science, Pharmaceutical, Biotechnology, Chemistry, Microbiology, or a related discipline.
• 5+ years' experience in a Quality Assurance role within a pharmaceutical or regulated manufacturing environment.
• Strong experience in supplier quality management, supplier qualification, and Quality Agreements.
• Knowledge of GMP, GDP, deviations, CAPAs, change controls, and supplier complaints.
• Experience reviewing technical and quality documentation.
• Strong communication, problem-solving, and technical writing skills.
• Proficient in Microsoft Office applications.

Desirable

• Experience in sterile or aseptic manufacturing environments.
• Exposure to validation, technology transfer, and Lean Six Sigma methodologies.