Qa Validation Engineer
1 week ago
The QA Validation Engineer is responsible for the Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with clients policies, FDA, European c GMP and GAMP standards.
Responsibilities Generation/maintenance/execution of Project Validation Plans and schedules.
Generation of validation protocols and final reports to c GMP standards.
QA support for validation investigations and implementation of corrective actions.
Creation/Review/Approval of various validation and qualification documents Management of validation, exception event, and change control processes.
Documenting all activities in line with c GMP requirements.
Performing cross training within the team and training of new team members.
Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
Coordinating activities to maximize the effectiveness of all of the team members.
Communicating with peers and management regarding activities in the area, including elevation of events or concerns Requirements 2+ years plus validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area.
2+ years plus of knowledge of c GMP and regulatory requirements relating to the pharmaceutical / medical device industry Strong communication (written and oral), presentation and troubleshooting skill required Effective interpersonal and organizational skills.
Ability to work well both independently and in a team environment.
Capable of prioritizing work and multitasking.
Job Type: Full-time Work authorisation: Ireland (required) Work Location: In person To start the process click the Continue to Application or Login/Register to apply button below.
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