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Validation Specialist – Computer Systems & Data Integrity

Validation Specialist – Computer Systems & Data Integrity
Excellent opportunity to join a thriving company with excellent professional development opportunities.

Key Responsibilities:

  • Support the business with the development and implementation of global and Site systems such as MRP, LIMS, Data Historians, support validation activities for process and QC computer control systems.
  • Lead the validation activities to ensure that the system is introduced in a manner compliant with governing regulations, specifically EudraLex Volume 4, including Annex 11, FDA 21 CFR 11 and Good Automation practices  (GAMP) as applicable. Ensure the system, including documentation, is maintained in an inspection ready state.
  • Support supplier assessments for GxP software suppliers/implementation partners and support internal audits of processes which involve the usage of these system.
  • Provide training and support for the validation and development of computer systems to project group as required.
  • Support and manage other quality and CSV resources and projects as defined by the business where required
  • Organise training and support to ensure users are proficient in the validation of compliance related computer systems as required.
  • Ensure data integrity requirements are maintained in the development, of computer control systems. 

 
Key Requirements

  • Educated to degree level in Human Health, Sciences or equivalent.
  • Minimum of 5 years experience working in a GxP environment with focus on QC / Process / IT compliance and CSV.
  • Effective written communicator, able to deliver concise documentation, adapting writing style to audience as appropriate.
  • Understanding of system development, implementation and management of Computer systems in Pharmaceutical applications.
  • Ability to dissect problems and solutions to provide a variety of unique options in a comprehensive manner.
  • Ability to work within a team, inspiring, motivating and challenging others as required.
  • Experience implementing, managing and operating IT systems.
  • Detailed understanding of GxP regulations and guidelines with regards to computer system validation and operation in a pharmaceutical manufacturing environment.
  • Fluent English
For further information please contact Loretta Flynn
Loretta@cregg.ie
086-1838380
Apply for this job

Job Details

Clare
27 June 2023
Job ID: 8422

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