Compliance Engineer

Dublin - Ireland

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Horizon Controls Group are seeking a Compliance Engineer who will be responsible for supporting Compliance activities at our clients

single use multi-product biotech facility.

Responsibilities include:

Ensure permanent inspection readiness within the team.

Support generation/review/approval of CSA deliverables.

Providing ongoing compliance (GxP Financial Data Privacy) coaching and support to all team

members.

Manage deployment of Global SDLC/CSA and IT Security policies and procedures.

Ensure supply of all compliance components required to deliver high quality product through

tactical planning and execution of project and compliance deliverables including change-control

periodic reviews performance monitoring system administration access administration disaster

recovery deviations incident problem management/investigations CAPAs audits policy

deployment cyber security data integrity EHS training etc.

Ensure highest Quality EHS & Compliance standards.

Active participation in the Tier process and proactively resolving issues.

Liaise with Compliance Engineers from other areas and support Site Quality Council and other site

quality initiatives.

Coordinate AIT Change-controls EHS activities and EHS/Quality metrics

Completion of AIT Investigations root-cause analysis and CAPAs

Strong project management skills to support project delivery and operational readiness.

Desirable:

At least 2 years experience in the planning document generation support or execution of CSV

activities in a biologic drug substance manufacturing plant.

A thorough knowledge of regulatory requirements associated with computer systems including EU

GMP Annex 11 21 CFR Part 11 is required.

Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and

PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP

Environments).

Experience in PLC/SCADA/DCS system

Contact George on or alternatively email me directly on

Horizon Controls Group are seeking a Compliance Engineer who will be responsible for supporting Compliance activities at our clients single use multi-product biotech facility.Responsibilities include: Ensure permanent inspection readiness within the team. Support generation/review/approval of CSA de...