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Regulatory affairs specialist

Limerick
beBeeCompliance
Regulatory affairs specialist
Posted: 26 February
Offer description

Compliance Manager Position

In this role, you will oversee and maintain all Clinical GMP Compliance aspects of procurement operations.

* Supervise progress on quality system results, including deviation investigations, CAPAs and change controls.

You will ensure the quality and accuracy of documentation as well as adherence to established due dates. This includes interfacing with Quality Assurance and other functional areas to remove obstacles, resolve conflicts, and facilitate critical decisions pertaining to quality system results.

* Perform deviation investigations and coordinate CAPA implementation as needed for high risk events.
The position involves continually reassessing Strategic Sourcing & Procurement systems and processes for adherence to Clinical GMPs and industry standards. You will implement changes/improvements as needed.
You are responsible for monitoring,
reporting,and responding
to Key Performance Indicators (KPIs) for the compliance functions,e.g.right-first-time (RFT)for deviation investigations.Your responsibilities also include representing the department on various topics during regulatory inspections,yet coordinating responses to inspection observations as applicable.The Approved Supplier List management along with Periodic Review of suppliers is another aspect involved.Managing audit closures by focusing proactive issue resolutions is a key part that needs active engagement.Gathering evidence relevant closure from suppliers makes task completion efficient.Compliance Manager should be able adapt fast-paced regulated environment,because some situations may need resolution quickly.Traditional analytical skills can prove an edge when it comes dealing complex data analysis other disciplines related fields.People skilled technical teams join our company who have professional experience in similar jobs.Demonstrated successful track record improve work efficiency.Effective teamwork communication enhances result.To get startedPlease Apply Now.We encourage diversity at Regeneron.

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