IT Compliance Analyst/Tech Writer

  • Reference: LK46783
  • Job Type: Permanent
  • Location: Clare, Limerick, Tipperary
  • Category: Information Technology

Collins McNicholas currently have an exciting opportunity for an IT Compliance Analyst/Tech Writer with one of their clients in the Mid-West Region. This role is a Permanent position.

 

The following are the key requirements for the role:

 

Responsibilities:

 

  • Ensures IT procedures are in compliance with regulatory and corporate requirements
  • Ensures IT personnel are operating in compliance with regulations and procedures
  • Assists IT personnel in interactions with Quality Assurance personnel and the Quality Management System 
  • Evaluates, develops and modifies IT Policies and Standard Operating Procedures to meet regulatory requirements and obligations
  • Provides IT with Technical Writing assistance
  • Tracks and reports on IT Quality metrics
  • Works closely with QA Validation to ensure IT systems are validated and maintained in a validated state
  • Represents IT or assists IT SME’s during in internal and external audits
  • Ensures IT Operational Controls are in place and maintained throughout the system lifecycle e.g. Periodic Reviews, Disaster Recovery testing, Performance Monitoring etc
  • Tracks that all IT Administration activities are completed as per procedures 
  • Champions Data Integrity for all IT systems
  • Represents IT at NOE/Deviation/Event meetings
  • Assists IT personnel in writing/responding to Deviation/Events including detailed event investigation and root cause analysis
  • Tracks and facilitates the remediation activities associated with IT-related CAPAs
  • Assists IT personnel in participating in and successfully navigating through the Quality Management Processes
  • Manages or assists IT SME’s with IT Change Controls
  • Ensures IT Training is adequate and current
  • Completes GAP assessments and remediation efforts

 

Requirements:

 

  • BS/BA in related field and a minimum of 5 years relevant experience preferred; will substitute relevant industry experience for educational requirement.
  • Strong preference for QA experience within an IT department
  • 3 years of pharmaceutical or biotechnology experience.
  • Knowledge of cGMP, 21 CFR Part 11, Annex 11, GAMP 5
  • Knowledge and experience of Quality Management Systems
  • Knowledge and experience of SDLC methodologies in a cGMP regulated environment

 

 

For a confidential discussion on the above role please contact Michael O’Leary on 061-512270


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Michael O'Leary

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  • Michael O'Leary
  • Recruitment Consultant
  • 061 512273
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