Sr QA Validation Specialist - Cleaning Validation

Regeneron

Limerick, Ireland

Validate/qualify cleaning processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

A typical day as a QA Validation Specialist, may include:

Generates, executes and/or reviews master and completed cleaning validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria;
Leads all aspects of cleaning validation for program to ensure program adherence in accordance with approved schedules;
Analyzes the results of testing and determines the acceptability of results against pre-determined criteria;
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements;
Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions;
Effectively communicate to key partners on cleaning validation programs (program adherence, success rate, issues/roadblock;
Reviews, edits and approves change controls, SOPs, reports and other documentation;
Coordinates with other departments or outside contractors/vendors to complete validation tasks;
Trains/advises less experienced Specialists;
Leads projects and prepares status reports;
May be required to supervise contingent workers;
Other duties assigned by management.

Knowledge Skills & Abilities:

Ability to maintain integrity and honesty at all times;
Ability to work independently or as part of a team;
Ability to communicate with transparency;
Continuously drive to improve processes for improved performance;
Demonstrate supportive behavior at all times;
Basic solid understanding of Microsoft Suite (Word, Excel, Powerpoint);
Captures and organizes information;
Meets commitments on time;
Effective time management skills;
Seeks to identify continuous improvement needs.

To be considered for this position you must hold a BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the field preferred; may substitute relevant experience for education.

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