QA Specialist: Supplier Quality & Compliance

Chanelle Pharma; Loughrea; On-site; EUR 65,000 - 90,000; Full time

Job summary

Chanelle Pharma in Ireland invites a QA Specialist - Supplier Quality Management to join the dynamic QA team at our Loughrea facility. You will take responsibility for supplier management activities and ensure materials meet registered specifications.

Reporting to the Senior QA Compliance Manager, you will maintain Approved Supplier Lists, coordinate supplier documentation (GMP certificates, CEPs, regulatory items), and lead supplier evaluations.

Qualifications

• Bachelor's degree in science
• Minimum of 3 years’ experience in a similar Quality Assurance role within the pharmaceutical industry desirable.
• Knowledge of EU quality-related pharmaceutical regulations.

Responsibilities

• Take overall responsibility for supplier management activities.
• Maintain Approved Supplier Lists (ASLs) and ensure supplier compliance across APIs, excipients, and primary packaging components.
• Coordinate sample evaluation and collate supplier compliance documentation, including GMP certificates, CEPs, TSE, GMO, allergens, elemental impurities, written confirmations, and other regulatory requirements.
• Ensure all supplied materials comply with registered specifications.
• Complete and maintain API Technical Agreements with suppliers.
• Manage vendor performance and generate associated management reports as required.
• Establish and maintain records of supplier performance and conduct vendor evaluations for new suppliers and materials.
• Support final supplier approval processes, liaising with cross-functional teams when implementing changes.
• Assist in the evaluation of materials proposed for R&D products.
• Clarify supply chain routes, including manufacturers, brokers, agents, and transport companies, and collate associated compliance documentation.
• Obtain supply chain route validation where required.
• Clarify and ensure compliance with required storage and transport conditions for all materials.
• Manage supplier risk assessments.
• Ensure supplier-related procedures are written, implemented, and adhered to.
• Ensure all activities are performed in compliance with regulatory standards and company policies, and that relevant personnel are trained accordingly.
• Identify and implement approved improvements to the Quality Management System.
• Carry out any other duties assigned by the Head of Quality or QA Manager.

Skills

Organisational skills

Cross-functional collaboration

Strategic decision-making

Quality processes

KPIs & prioritisation

Proactive mindset

Pragmatic workload mgmt

MS Office

Education

Bachelor's degree in science

Job description

Chanelle Pharma in Ireland invites a QA Specialist - Supplier Quality Management to join the dynamic QA team at our Loughrea facility. You will take responsibility for supplier management activities and ensure materials meet registered specifications.

Reporting to the Senior QA Compliance Manager, you will maintain Approved Supplier Lists, coordinate supplier documentation (GMP certificates, CEPs, regulatory items), and lead supplier evaluations.