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Job ID: JOB-13242

Senior QA Validation Specialist- Cleaning Validation

Purpose

The purpose of the Senior QA Validation Specialist- cleaning validation 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.
• 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 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 behavior 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 Aisling Kidney on 0872197421 or careers@hero.ie

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

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Aisling Kidney

JOB-13242

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