This is a 6-month contract initially and is a hybrid position.
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
• 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
• Bachelor Degree or higher preferred; ideally in a related Science discipline
• Lean Six Sigma Methodology experience desired
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Apply For This JobTo apply for this job email your details to rachael.kennedy@theaphexgroup.com.
To apply for this job email your details to rachael.kennedy@theaphexgroup.com.