Job Description
A IT Compliance Analyst (Technical Writer) is required on a contract role by CareerWise Recruitment for our Irish based client.
Role of this position
Our client is a leading biotechnology company known for its innovative approaches in developing medicines for serious diseases and they are looking for a IT Compliance Analyst who will be responsible for ensuring that the IOPS IT group is operating in compliance with Regulatory requirements and internal procedures as well being the key liaison between the IT and Quality Assurance group
RESPONSIBILITIES:
* Provides Technical Writing assistance with the creation/updating of Documents.
* Provides Technical Writing assistance with the management of Change Controls, Deviations, CAPAs.
* Provides Technical Writing assistance with the completion of System Periodic Reviews.
* Supports the execution of System Audit Trail Reviews.
* Tracks and reports on IOPS IT Quality Metrics.
* Champions Data Integrity for all IT systems
* Represents IOPS IT at various site/cross-site meetings.
* Ensures IOPS IT procedures follow regulatory and corporate requirements.
* Ensures IOPS IT personnel are operating in compliance with regulations and procedures.
* Help ensure the training provided to IOPS IT Training personnel is adequate.
* Represents IOPS IT or assists IOPS 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.
JOB REQUIREMENTS
* BS/BA in related field and a minimum of 2+ years relevant experience preferred; will substitute relevant industry experience for educational requirement.
* Excellent people and communication skills
* Troubleshooting and analytical mindset