Regulatory Compliance Officer

Job Overview

A Regulatory Compliance Officer job has become available with an international chemical company in Tipperary

This company are experiencing year on year growth and I am excited to be assisting them to recruit for a Regulatory Compliance Officer to join their small Quality team on a permanent basis, pharma background essential. This is a lovely, varied role ,working in a small team that will fully support you and will see you charged with supporting quality, regulatory and compliance aspects of sourcing & procurement operations.

Duties and Responsibilities:

* Maintain the Quality Management System

* Ensure company compliance with relevant legislative requirements, e.g. EU, UK and China REACH

* Implement and maintain the quality standards

* Manage the Vendor Approval Process,

* Organise assessment of vendors prior to vendor review meeting.

* Ensure that the HACCP Plan is reviewed and updated as necessary.

* Schedule and complete internal audits

* Monitor customer complaints and non-conformances .

* Accompany external auditors when carrying out third party audits

* Conduct Quality Risk Assessments and review as necessary.

* Ensure that the quality objectives and KPIs are being completed for each department.

* Responsible for HPRA Registrations

* REACH Articles completion

* Liaise with Emergency Response Provider.

* Liaise with REACH Consultant Service Provider

* Conduct HSA, REACH Compliance audits in association with Quality & Compliance Manager

Person Specification

* Minimum of 3-5 years' experience and a thorough knowledge of Quality Systems, Quality Assurance, Compliance, Reg Affairs in the pharmaceutical industry.

* Relevant qualification in Quality and Regulatory matters

* Good auditing skills.

* Strong numeracy, verbal and written communication skills.

* Good computer skills.

* Attention to detail and confidentiality is a must for this role.

* Ability to work under pressure and meet deadlines.

* In-depth knowledge of relevant statutory and regulatory requirements

* Willing to travel if required.

To succeed in this challenging role, you will have experience of managing a varied workload ,you will be confident dealing with a wide range of people, possess excellent communication skills and have a proactive, pragmatic approach and excellent people skills.

It is essential that applicants hold entitlement to work in Ireland

Please refer to the Job Description while completing your application as candidates will be shortlisted based on how closely they match the criteria.

For a more detailed discussion on this new Regulatory Compliance Officer Job-Tipperary please contact Kerry 086 0443981

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