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QA Rep Engineering

I7498

QA Rep - Engineering The successful QA Rep Engineering will have a BSc (Hons) Micro, Engineering, Biochemistry, Chemistry, Analytical or a related discipline with ideally a minimum of 2 years similar QA experience.

Category:
Engineer Chemical
Location:
Munster
Years of Experience Req.:
1 years +
Date Posted:
08/07/2019
Days Remaining:
9
Employment Type:
Contract
Education Level Req.:
Third level qualification

QA Rep Engineering

The successful QA Rep Engineering will have a BSc (Hons) Micro, Engineering, Biochemistry, Chemistry, Analytical or a related discipline with ideally a minimum of 2 years similar QA experience.

 

Key Responsibilities:           

-      Quality oversight of and guidance to a Biotech project

-      Maintenance of all aspects of GMP compliance for the area(s) of responsibility

-      Establishment, maintenance and management of a control system for the specific Quality System(s)/Program

-      Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program

-      Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program

-      Review and approval of change controls and failure investigations, associated with the area(s) of responsibility

-      Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.

-      Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, GMP utilities and periodic quality evaluations.

-      Review and approval of other key GMP documents such as GMP standard operating procedures, specifications, process flow diagrams as appropriate to area of responsibility

-      Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in area of responsibility

-      Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility

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