QC Analyst

Collins Mcnicholas Recruitment

Cork

Role Responsibilities: 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 team members as appropriate. Collaborates across multiple lab groups and with other sites. Role Requirements: 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. Strong analytical skills. Acute attention to detail. Adaptable and flexible. Excellent team player with strong customer focus. Knowledgeable of FDA/EMEA regulatory requirements. For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs! This job originally appeared on RecruitIreland.com.

1894 days ago