QC Analyst

  • Cork
  • Temporary 18 months
  • JO-1901-64177_1548174497

Summary

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 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 Janssen sites
  • Developing and qualifying the electronic data management processes for the QC team

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.

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