Specialist Qa

Details of the offer

Excellent opportunity for a QA Specialist with a leading Life Sciences company located in the North West of Ireland. The QA Specialist ensures product manufacturing complies with GMP and Regulatory standards. Responsibilities include validating facility, equipment, and utilities, as well as reviewing and approving validation documentation. This individual contributor role requires a self-starter with expertise in QA and validation, facilitating collaboration with departments like Quality Control, Manufacturing, Engineering, and Technical Services.
Overview of your responsibilities: Provide technical expertise and guidance on QA and compliance topics, including validation strategy, new product introduction, and manufacturing issue resolution.
Manage assigned QMS areas, including Deviation, Change Control, CAPA, audits, complaints, vendor management, and approval of batch records and production materials.
Generate, review, and approve SOPs/documentation in designated areas.
Timely review and approval of site procedures to ensure GMP and regulatory compliance.
Review and approve validation protocols/reports to meet EU regulatory expectations.
Maintain GMP/validation document review to support technology transfers and NPI.
Apply Quality Risk Management principles as needed.
Lead QA activities in project work-streams involving cross-functional teams.
Knowledge, Skills and Experience Required for the Role: Third-level qualification in relevant science or engineering discipline.
Minimum 5 years of experience in a GMP Quality environment.
Experience in Validation function with strong knowledge of Project Life Cycle and cGMP.

#J-18808-Ljbffr


Nominal Salary: To be agreed

Source: Jobleads

Requirements

Mobile Engineer (React Native)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum ...


Abbott - County Sligo

Published 25 days ago

Senior System Engineer - Siemens

SL Controls provides Equipment System Integration solutions to manufacturers, particularly those in the life sciences and technology sectors. Due to the ongo...


Sl Controls Ltd - County Sligo

Published 25 days ago

Technical Support Specialist

About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans ...


Abbott - County Sligo

Published a month ago

Level 1 Deskside Support Engineer – Dublin

ICT Services is currently looking for a Level 1 Support Engineer to work for one of our customers located in Blanchardstown. The successful candidate will tr...


Ict Services - County Sligo

Published 18 days ago

Built at: 2024-11-13T10:13:18.581Z