QC Analyst-Lab Services- 18 month contract

  • Cork
  • Contract 18 months
  • JO-1901-64190_1548847740

Summary

QC Analyst - Lab Services -18 month contract

RESPONSIBILITIES
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
* 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 Janssen sites


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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