Our client, an expanding site in the biotech space are 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 experience with a degree in biopharmaceuticals or biomedical and have
a working knowledge of quality mgt systems, deviations, vendor mgt, 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 SOP's/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 [email protected] for more insights on this role.
