20859-Quality Auditor-Carlow Contractor

This is a 6-month contract initially and is a hybrid position.

Purpose

The role will support validation and qualification activities and will liaise with technical subject matter experts to ensure that equipment in use on-site is validated and re-validated per global and local procedures and maintains compliance

Responsibilities

•  Responsible for helping to ensure that the validated equipment on site maintains validated status.

•  Act as quality support for validation and qualification activities of equipment, facilities and associated processes on site to ensure they are maintained in accordance with global and local procedures

•  Ensure that quality issues are identified, addressed, and resolved in a timely manner

•  Responsible for supporting deviation close out and initiating/following up on corrective and preventative actions

•  Partner with colleagues cross-functionally to provide support and advice on a day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, etc

•  Demonstrated ability in pharmaceutical equipment validation/qualification or quality support for same

•  Knowledge of EU/US quality-related pharmaceutical regulations

•  Experience in Sterile manufacture preferred

•  Ideally a minimum of 3 years experience in the FDA and/or EU-regulated pharmaceutical environment; preferably in a manufacturing site in quality and/or engineering roles

•  Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards and Practices requirements.

•  Knowledgeable in Industry Best Practices for quality and compliance-related topics

•  Proven ability to effectively initiate and drive change

•  Strong verbal and written communication skills, project management skills

•  Report, standards, and policy writing skills required

•  Proficiency in Microsoft Office and job-related computer applications required (electronic validation systems)

•  Good Collaboration Skills

•  Ability to work as part of a team to determine priorities

•  Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance

•  Demonstrated ability to drive the completion of tasks

•  Proven decision-making capability with accountability and responsibility

•  Demonstrated ability to solve problems

Requirements

•   Bachelor Degree or higher preferred; ideally in a related Science discipline

•  Lean Six Sigma Methodology experience desired