Specialist QA
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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.
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.
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