Responsibilities

• The Business Analyst will provide IT implementation\remediation\retirement support to the Automation team and the to ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), Cyber Security and Data Integrity.
• Prepare plans for remediation of legacy systems and implementation of new systems
• Deliver effective and efficient running of CSV Compliance
• Provide Compliance support, guidance and expertise e.g. Perodic Reviews. 
• Strong knowledge of Microsoft® Windows Operating Systems (Windows 7/10 and Windows Server 2003/2008/2012/2016).
• GMP documentation knowledge, generation, review, execution on electronic systems (MIDAS, Kneat, Veeva)
• Basic Knowledge of Active Directory and Windows File Security permissions.
• Protecting system by defining access privileges, control structures, and resources.
• Attend workshops to outline and finalize the requirements specifications for new applications.
• Maps and models business processes and information specific to the shop floor manufacturing.
• Migrate applications\data from legacy operating systems to newer supported operating systems.
• Implementing business improvements through more effective use of Applications.
• Participates in training programs in the area of responsibility.

Qualifications & Education

• Experience implementing and managing applications commonly used in GxP manufacturing process.
• Computer Systems Validation experience is desirable.
• Degree qualification (BSc, Engineering, Technical). 
• Experience working within a regulated environment.
• Experience of supporting regulatory systems is preferred but not essential.
• Very Strong Collaboration and Communication Skills
• Extensive technical, operational and business expertise in the following disciplines:
• 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.
• Computer Systems Validation
• EU Annex 11
• 21 CFR Part 11
• MHRA (UK) GMP Data Integrity guidelines
• Sarbanes-Oxley (SOX ) regulations
• Data Integrity

To apply contact Martin Lynch on 087-344 3581. Email CVs to mlynch@mile.ie