Lims Analyst - Lab Services
PE Global is currently recruiting for a LIMS Analyst for a Client site in Cork: POSITION SUMMARY: QC Analyst – Lab Services - 12 months. The QC Analyst – Laboratory Services will be responsible for the following. • Developing and qualifying the electronic data management processes for the QC team. • Administrating and maintaining Laboratory electronic systems. You will have fulfilled the educational requirements for this role and have experience in a similar role within a FDA/EMEA regulated environment. What you’re great at: • Strong analytical skills. • Excellent communication, written and oral. • Acute attention to detail. • Adaptable and flexible. • Excellent team player with strong customer focus. • Knowledgeable of FDA/EMEA regulatory requirements. As an QC Analyst – Laboratory Services, your typical day may include: • Administrate and maintain QC Laboratory systems such as eLIMS, LES, Empower 3, SDMS and Softmax Pro. • Providing day to day operational & training support for laboratory systems. • Completion of necessary software systems documentation reviews including periodic reviews, data integrity reviews and SOP updates. • Creating and managing Empower projects, user accounts, instrument methods, method sets, report methods and processing templates. • Interacts and represents the Cork site on Global COEs related to laboratory systems. • Ensure laboratory systems are compliant with the data integrity requirements of all applicable regulatory guidelines. • Author, review and approve change controls, CAPAs, laboratory investigations, deviations, SOPS and work instructions, qualification protocol, reports etc. • Anticipates and plans for future requirements in the area. • Deals with events/ deviations in an accurate and timely manner. • Identifies opportunities to improve the services provided e.g. new technologies, improved vendor processes, cost, quality etc. • Supports QC where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc. • Deputizes for the supervisor and other ream members as appropriate. • Collaborates across multiple lab groups and with other sites. To be part of this high performing team you will have great attention to detail, alongside. • BSc Hons (or Higher) in a Science or related discipline. • A minimum of 2 years’ experience in a similar role within a laboratory environment. • Excellent social and communication skills. • Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), service management, IT project lifecycle and other regulatory requirements or policies. • Self-driven and keeps up to date with regulatory, technical developments within the industry. • Focus on patients and customers at all times. Interested candidates should send their CV toAudrey.email@example.com call 0214297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.
287 days ago