QA Specialist
6 days ago
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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 WFH as project requires.
They are seeking applicants that have 3-5 years of 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, multi-department teams including Operations, Quality Control, Quality Assurance, Engineering, and others.
- Actively contribute to continuous improvement activities.
Reach out for more insights on this role.
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