Senior QA Validation Specialist

Purpose

The purpose of the Senior QA Validation Specialist is to Validate/Qualify cleaning processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

Key Responsibilities

• 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
• Oversees cleaning validation for program to ensure program adherence in accordance with approved schedules.
• Analyses 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 stakeholders 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.
• Manages projects and prepares status reports.
• May be required to oversee contingent workers.
• Other duties assigned by management

Knowledge and Experience

• 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 respectful behaviour at all times
• Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint)
• Gathers and organizes information
• Meets commitments on time
• Follows directions; performs well-defined tasks
• Effective time management skills
• Seeks to identify continuous improvement needs
• To be considered for this role 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.

For further information on this role in Limerick please contact Julie on 086 816 8298 or hireme@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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