Quality Engineer
Sligo – Permanent
I am looking to speak with candidates with Quality Engineering or QA specialist experience in a GMP Quality environment for a growth role in this expanding company.
The successful candidate will support review and approval of validation documentation and activities related to the qualification of the facility, equipment and utilities to support start-up and on-going manufacturing.
Day to day duties ;
· Review and approval of validation documentation and activities
related to the qualification of the facility, equipment, and utilities to
support start-up and on-going manufacturing.
· 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 investigations,
Change Control and CAPA management systems; Internal/External audits; 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.
· 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
including the application of risk assessment tools such as FMEA
· 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.
For a confidential chat, please reach out to [email protected]
#LI-AM6
