Quality Assurance Specialist (Supply Chain)

CareerWise Recruitment; Limerick; On-site; EUR 55,000 - 80,000; Full time

Job summary

CareerWise Recruitment is seeking a QA Specialist (Supply Chain) for our Limerick-based pharma client. The role requires leading quality governance, managing GMP compliance, and overseeing supplier interactions within the Quality System.

Responsibilities include documenting controls, approving GMP-related documents, and ensuring regulatory alignment across quality programs. Strong emphasis on site safety, audits and vendor evaluations to maintain high quality standards.

Qualifications

• BSc, MSc or PhD in Biotech, Chemistry, Engineering or related discipline.
• 3 years relevant experience.

Responsibilities

• Provide Quality leadership, direction and governance for the specific area of responsibility.
• Manage quality-related matters specific to area of responsibility.
• Approve appropriate quality-related documents; signature confirms GMP requirements have been met.
• Carry out day-to-day activities in compliance with site safety policy and procedure, promoting safe practices.
• Ensure consistent implementation of standards across the quality system.
• Maintain GMP compliance for the area(s) of responsibility.
• Establish, maintain and manage a control system for the specific Quality Systems/Program.
• Interpret and apply emerging regulatory & GMP guidelines to the Quality Systems/Program.
• Benchmark current and emerging initiatives in the Quality Systems/Program.
• Own/review/approve change controls and deviations with Supplier Management.
• Report and escalate critical quality issues to quality management for resolution.
• Monitor GMP compliance, programs and systems with regular presence in the area.
• Evaluate, audit and approve 3rd party suppliers/contractors for the area.
• Contribute to the Quality plan for specific initiatives.
• Maintain vendor files for service providers, materials and consumables; support audits and vendor evaluations.

Education

BSc, MSc, or PhD in Biotech, Chemistry, Engineering or related discipline

Job description

QA Specialist (Supply Chain) is required by CareerWise Recruitment for our Limerick based Pharma client.

Responsibilities:

• Provide Quality leadership, direction and governance for the specific area of responsibility.
• Manage quality-related matters specific to area of responsibility
• Responsible for approving appropriate quality-related documents. Approval signature confirms that GMP requirements have been met.
• Carry out day to day activities in compliance with site safety policy and procedure. Promote and encourage safe practices and promptly report any safety concerns.
• Assures consistent implementation of standards across the quality system.
• Maintenance of all aspects of GMP compliance for the area(s) of responsibility.
• Establishment, maintenance and management of a control system for the specific Quality System(s)/Program.
• Interpretation and application of emerging regulatory & GMP guidelines to the specific Quality System(s)/Program
• Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program.
• Own, review or approve change controls (including implementation steps), deviations (including tasks) associated with Supplier Management.
• Reports & escalates critical quality issues to the appropriate level of quality management for final resolution.
• Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in the area of responsibility.
• Evaluation, audit and approval of 3rd party suppliers/contractors as appropriate for the area of responsibility.
• Contribution to the Quality plan for specific quality system/program initiatives.
• Maintains the vendor files for service providers, materials and consumables (generation of audit plans and Q agreements, assists in scheduling of local, national and international audits, manage vendor file periodic reviews as per local SOP, ensure all vendor file content is current and appropriately documented, monitor and modify the supplier evaluation process as required).
• Generate and maintain vendor files for materials (liaise with purchasing to define supply chain, complete risk assessments in conjunction with procurement and MS&T, participate in the new item code process, approval of material and vendor package, re-evaluation of vendors

Requirements:

• BSc, MSc, or PhD in Biotech, Chemistry, Engineering or related discipline
• 3 years relevant experience.

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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