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QA Engineering Manager

Posted on May 29, 2021 by Elevate Direct

Louth, Ireland
Immediate Start
Annual Salary

QA Engineering Manager

The ideal candidate will be the primary QA contact for C&Q activities of the manufacturing facility and act as local QA representative to provide daily computer system quality oversight and guidance.

The Responsibilities:
Assist in installation and testing of equipment, commissioning of systems, and validation of test equipment for new manufacturing facility.
Review process change control documentation and specifications
Work with the validation team on activities such as: Equipment qualification, production process validation, room qualifications, automated equipment and control systems etc
Review validation documentation including URS, DR, Criticality assessments, CSV protocols and validation reports.
Provide Technical Assessments to Change Controls/CAPA's, Non-Conformities and Suppliers Qualification.
Continuous improvement on validation process and procedure.

The Requirements:
Bachelor degree or higher in a relevant discipline.
5+ years of experience in the biotech/pharmaceutical/biopharma industry
2+ years in QA function, including experience with audits and regulatory inspections.
Excellent working knowledge of Eudralex and FDA (GxP) regulations, ICH standards and GAMP methodologies.
Experience in computer system validation in qualifying Electronic Batch Management systems preferred.
Direct experience performing equipment validation.

Reference: 1211530108

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