QA Specialist

4 months ago

Cork, Ireland Westbourne IT Global Services Full time

Main Purpose and Objectives of Position:

·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 company and 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

Key Responsibilities:

·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.

·Audit and participation in the site self inspection program for the area of responsibility for compliance with GQS & local procedures

·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

-Records and Information Management (RIM) Steward (Coordinate annual site wide Document Clean-Up Day, Owner of Documentation Collab space and E-archive)

Educational Requirements:

BSc, MSc, or PhD in Biotech, Chemistry, Engineering or related discipline, with a minimum of 3 years relevant experience.

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