QC Instrument Validation Specialist (1 Year FTC)

A fantastic opportunity to validate new QC equipment at our Cork Site. 

The Thrombosis Business Unit is uniquely positioned to make a significant difference for patients. We focus on high-risk patient groups and supporting healthcare systems with high quality medicines. Every year thousands of health care providers and millions of patients rely on our products and services.

Our exceptional history holds more than 80 years’ experience to prevent and treat thrombosis, building expertise and strong relations within our field. Across the world, our dedicated teams continue to innovate and evolve to best serve our customers, making a meaningful impact for patient care.

In the Quality Control Labs we share a “challenge accepted” mindset and are guided by our winning behaviors of simplification, collaboration, and accountability, to achieve our goals
 

Your new role

Manage QC Instrumentation within the QC Laboratory in LEO Pharma Cork:

• New laboratory equipment introduction
• Preparation and execution of instrument URS (User Requirement Specification) /FS (Functional Specification), IQ (Instrumental Qualification) /OQ (Operational Qualification) /PQ (Performance Qualification) documents.
• Organize (vendor/supplier/service engineer contact), review and approval of external PM’s, IQ, OQ, PQ and instruments calibrations, 
• Operating in PEMAC systems and new instrumental implementation. 
• Instrumentation SOP’s updates and reviews,
• Change Controls set up and action execution,
• H&S Risk Assessment preparation.
• Lab. equipment decommissioning 
• Technical and Quality review of vendor and internal protocols and documents

Your qualifications

To succeed in this role, we imagine that you have the following qualifications:

• Third level degree qualified in scientific or related discipline.
• Experience with QC Equipment validation and Instrumentation within a GMP environment supporting the pharmaceutical industry.
• Preferred experience with HPIC and HPLC equipment validaton.
• Experience of Microsoft Office, Quality Management Systems, Empower software. 
• Strong team player with the ability to work collaboratively and cross functionally 

LEO Pharma is built on collaboration, innovation and curiosity. Is this you? Can you bring this and Ability to work on own initiative with excellent organisation and communication skills to this role? 

Your application

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.