Quality Assurance Specialist (Supply Chain)

CareerWise Recruitment; Limerick; On-site; EUR 55,000 - 75,000; Full time

Job summary

CareerWise Recruitment is seeking a QA Specialist (Supply Chain) for our Limerick-based pharma client. You will provide quality leadership, governance and ensure GMP compliance across the area of responsibility.

Responsibilities include approving quality documents, ensuring safety practices, maintaining GMP standards, and managing supplier interactions and audits. 3 years relevant experience and a Biotech/ Chemistry/ Engineering background are required.

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 and ensure GMP requirements are met.
• Approve appropriate quality-related documents; GMP sign-offs.
• Carry out day-to-day activities in compliance with site safety policy and promote safe practices.

Skills

Quality leadership

GMP compliance

Vendor management

Education

Biotech / Chemistry / Engineering degree

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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