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Job Post Details

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Compliance Engineer - job post

Horizon Controls Group
3.0 out of 5 stars
Dublin, County Dublin

Location

Dublin, County Dublin

Full job description

Horizon Controls Group are seeking a Compliance Engineer, who will be responsible for supporting Compliance activities at our client's

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 CAPA’s

·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 0871897038 or alternatively email me directly on GMcGlone@Horizon-controls.com
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