Job Description
An 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, a leading biotechnology company, is known for its innovative approaches in developing medicines for serious diseases. We are seeking an IT Compliance Analyst responsible for ensuring the IOPS IT group operates in compliance with Regulatory requirements and internal procedures while serving as 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.
* Supports the completion of System Periodic Reviews.
* Executes 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.
* Maintains IOPS IT procedures align with regulatory and corporate requirements.
* Ensures IOPS IT personnel operate in compliance with regulations and procedures.
* Supports the training provided to IOPS IT Training personnel.
* Represents IOPS IT or assists IOPS IT SMEs during internal and external audits.
* Establishes and maintains IT Operational Controls throughout the system lifecycle.
Job Requirements:
* Bachelor's/Associate's degree in a related field and 2+ years of relevant experience (will substitute relevant industry experience for educational requirement).
* Excellent communication and interpersonal skills.
* Troubleshooting and analytical mindset.