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AIT Compliance Coach

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: Risk & Compliance
  • Date posted: 10/10/2018
  • Job reference: BBBH90101

AIT Compliance Coach

JOB DESCRIPTION

The Compliance Coach will provide IT compliance/validation support to an Automation & IT (A&IT) Team and the general site to ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), Cyber Security and Data Integrity for manufacture and supply of quality pharmaceutical products.

Ensure that plans are prepared for remediation of legacy systems and implementation of new systems meeting a defined set of infrastructure and architecture required to support the business. Prepare and govern a target state for A&IT architecture onsite, particularly for networks and cyber security requirements. Work with Automation groups within AIT to develop roadmap and target state and deliver ruthless standardisation to ensure stable supply and compliance.

The A&IT Compliance Coach is accountable for the effective and efficient running of all CSV Compliance operations in the A&IT team and across the site.

RESPONSIBILITIES

  • Providing ongoing compliance coaching and support to all team members.
  • Manage deployment of Global SDLC/CSV 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.
  • Participates in audits and training programs.
  • Coordinate AIT Change-controls, EHS activities and EHS/Quality metrics.
  • Completion of AIT Investigations, root-cause analysis and CAPA's.

EXPERIENCE & SKILLS REQUIREMENTS

  • Degree qualification (Science, Engineering, Technical).
  • Minimum 8 years of experience and critical skills in their area of expertise.
  • Extensive technical, operational and business expertise in the following disciplines:
    • Computer Systems Validation
    • Instrumentation/Automation & Control
    • Project Management
    • Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with vendors, contractors and external customers.
    • Demonstrable analytical and systematic problem-solving skills.
    • Ability to liaise with above-site networked/matrixed IT and Quality functions.
    • Demonstrated ability in holding team members accountable for results.