Validation Quality Specialist

Validation Quality Specialist
AMC20859
Contract – 6 months
Hybrid – 50% onsite
Carlow

URGENT HIRING NEED

We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

In this role you 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.

Key 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 day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations etc

• Bachelor Degree or higher preferred in Science
• 3+ years experience in FDA/EU regulated pharmaceutical environment
• Experience in a similar role providing validation and or quality support for pharmaceutical manufacturing equipment
• Sterile manufacturing experience (preferred)
• Lean Six Sigma Methodology experience (desired)