Job Title : Sr.Functional Analyst (ISG)
Job Summary : The Lab Computer System Validation Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations. We are seeking an enthusiastic and experienced Lab CSV Engineer to join our team. The Lab CSV Engineer will provide systems validation and compliance expertise for newly purchased instruments and support of existing instruments. The position will work within a collaborative Computerised Instruments team and will be required to have excellent communication/i
Experience : 6 - 8 years
Required Skills : Technical Skills: Empower other Lab systems Labware any LIMS CSV Domain Skills:
Nice to have skills : Domain Skills:Manufacturing and Supply Chain
Technology : Custom Service
Shift : Day
Responsibilities : Minimum 3 years experience supporting and validating lab equipment updating documentation system testing troubleshooting Experience of analyzing and challenging s/w to identify gaps. Knowledge of 21CFR Part 11 requirements ER/ES and data integrity guidelines is desirable Strong oral and written communication skills are required with proven ability to communicate and build relationships cross-functionally Self-motivated detail-oriented and excellent organizational and time management skills Capable of relating well to other people with whom s/he comes in contact both within and outside of the laboratory area Manage lab equipment validation projects from software install to business release Prioritize CSV activities in line with the project schedule and monitor budgets Generate computer system validation documentation e.g. Design Spec Configuration Spec Testing Security Plan Test Summary Report in accordance with site procedures and GMP guidelines Review of software release notes Liaise with service providers to determine successful installation of instrument software and ensure correct configuration Determine any specific configurations for the software e.g. how data is saved and named Understand and define user permissions Execute test scripts analyse test results and determine the acceptability of results against pre-determined criteria Work with the business to identify and implement procedural controls to mitigate issues found during testing Initiate and implement Change Control activities in accordance with Quality Standards and Practices Determine solutions or recommendations for changes and/or improvements Produce documentation that is well written and consistent throughout the document body e.g. headings font type font size paragraph spacing text alignment correct tense Follow all relevant Environmental Health and Safety procedures and assist in incident investigations as required
Job Location : Primary Location :IECRCORC01(ITIRL Cork - CR IRL CLT/RMT) Alternate Location :NA NA Alternate Location 1 :NA NA
Job Type : Sr.Functional Analyst (ISG) [60SG00]
Demand Requires Travel? : No
Certifications Required : NA