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View Cache (Job ID 13850187)
Employer ICDS Recruitment
Job Title Esystems Compliance Officer

eSystems Compliance Officer - County Waterford.

Our client is looking for the ideal candidate to ensure that site automated systems are introduced, maintained and operating in accordance with cGMP’s, site and corporate policies and regulatory requirements with a keen focus on Data Integrity.


  • Support, review and approve automated system policies and procedures ensuring compliance with cGMP’s, site and corporate policies and regulatory requirements
  • Liaise with local and global team members for validation and compliance activities regarding current and future automated management systems
  • Quality sign off for computer system validation documents, and other ancillary documentation supporting eSystems projects
  • Support regulatory inspections and internal audits with a focus on 21 CFR Part 11; EU GMP Annex 11, GAMP and Data Integrity requirements.
  • Evaluate Change Controls, CAPAs and deviations related to eSystems
  • Assist cross-departmental teams in authoring validation related documentation, standard operating procedures, reports, system quality reviews, identifying deficiencies, preparing CAPA’s, test scripts and change controls
  • Ensure the Automated Systems Inventory and schedule is up to date at all times.
  • Prioritize, manage, and execute multiple projects utilizing Project Management methodology
  • Ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Perform additional team tasks as agreed to support effective running of the Business
  • Check own work and that of others for accuracy ensuring that all work is documented thoroughly


  • Degree in pharmaceutical science, quality management, computer science, computer engineering, life science or similar
  • At least 3 years' relevant experience in pharmaceutical industry, within a quality or IT function
  • In-depth knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation
  • Extensive knowledge of validation deliverables associated with each step of the computer system life cycle
  • Knowledge and proven application of established risk management processes

This job originally appeared on
Location Waterford
Date Added 68 days ago
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