Validation Analyst

Job Description

Role: Validation Analyst

Location – Dunboyne, Ireland

Primary & Secondary Skill 

Validation Analyst / Computer System Validation (CSV)


 

JD (Detailed) 

Preferred Skills:
• Minimum 3-5 years’ experience in the Pharmaceutical industry or a similar operating environment, with a strong emphasis on Lab Systems.

e or in a similar role

• Strong understanding of manufacturing processes and safety regulations

• Extensive experience in equipment calibration, performance testing, and quality control.

• Experience in IT related documentation process (IQ/OQ & SDLC)
• Prior QC Lab experience with analytical instrumentation qualification and system implementation.
• Excellent written and verbal communication skills to effectively communicate with technical and business users.
• Experience with working in a multinational organization. 

Job Roles/Responsibilities: 
• The Delivery Lead will act as a bridge between business challenges and technology solutions will work under leadership of the Site IT and will maintain a close relationship with a network of Global Infrastructure Operations and Support teams in Site IT as well as the operational teams at the site.
• The Lab IT Lead will focus on planning and execution of Quality & Laboratory information systems projects including the building, configuration, qualification and validation of servers and PC’s for use in a GxP environment according to GAMP 5 and CFR 21
• Additionally, the Lab IT Lead  will assure full and continuous compliancy with regulatory and company requirements, for example CSV and SDLC.
• Support the review & approval of key quality deliverables including SDLC, Change control, Deviations, CAPAs.  Etc. 
• Attend periodic review meetings, cutover migration, hyper care support, any enhancements planning, design and/or implementation meetings as required.
• Good at customer handling and liaising with all stakeholders.