Qa Specialist

Our client, an expanding site in the biotech space, is currently recruiting for a Quality Assurance Specialist.
Sligo – Permanent - Onsite initially with option of some work from home as project requires. They are seeking applicants that have 3-5 years experience with a degree in biopharmaceuticals or biomedical and have a working knowledge of quality management systems, deviations, vendor management, change controls, CAPA's, and batch record release.
This is a permanent role and has excellent opportunities for growth.
RESPONSIBILITIES:Site QA point of contact providing technical expertise, feedback, and guidance for QA and compliance topics/issues including new product introduction and manufacturing, and assist in the resolution of issues commensurate with the level of risk.Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.QMS areas of responsibility include Deviation, Change Control and CAPA management systems; Internal/External audits; Customer Complaints; Vendor Management; review/approval Manufacturing Batch Records and assessment/approval of production materials.Generate, review, and approve SOPs/other documentation as applicable to your areas of responsibility.Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.Review and approval of validation protocols/reports and related documentation to ensure compliance with current EU regulatory expectations and site procedures.Ensure schedules for review and approval of GMP/validation documents are maintained to support technology transfers and new product introduction project timelines.Ensure application of Quality Risk Management principles as applicable.Act as the QA lead in QA activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering, and others.Actively contribute to continuous improvement activities.Reach out to ****** for more insights on this role.

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