Validation Analyst

Role: Validation Analyst

Employment Type TP

Location Dunboyne Ireland

Primary & Secondary Skill

Validation Analyst / Computer System Validation (CSV)

JD (Detailed)

Preferred Skills:
Minimum 35 years experience in the Pharmaceutical industry or a similar operating environment with a strong emphasis on Lab Systems.

Previous experience as a validation engineer 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.