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Regeneron Ireland

IT Compliance Analyst

Regeneron Ireland

  • Limerick
  • See description
  • Permanent full-time
  • Updated 15/12/2017
  • Regeneron Pharmaceuticals
this job is expired
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Description

he IT Compliance Analyst is responsible for ensuring that the IT group is operating in compliance with Regulatory requirements and Regeneron internal procedures as well being the key liaison between the IT and Quality Assurance groups.

 

Regeneron offers a unique, world-class opportunity for interested candidates. Regeneron has been consistently ranked a "Top Employer" in Science Magazine's rankings for pharmaceutical and biotechnology companies. Regeneron is fully committed to bringing its award-winning approach to Regeneron Ireland, its subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged.

Summary: The IT Compliance Analyst is responsible for ensuring that the IT group is operating in compliance with Regulatory requirements and Regeneron internal procedures as well being the key liaison between the IT and Quality Assurance groups.

Essential Duties and Responsibilities include, but are not limited to, the following:
* 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

Education and Experience:
* 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 and Skills:
* 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

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron Ireland is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, family status, marital status, age, disability, sexual orientation, religion, race, national or ethnic origin, gender identity or any other characteristic protected by law.



To apply for this position please click here

Ref: 11365BR_1511945069
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Regeneron Ireland

Regeneron Ireland

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