Orlaith Halligan

• Evaluate Maintenance and Instrumentation Registrations ensuring precise content.
• Initiate and oversee Engineering Change Controls.
• Generate new and revise existing Equipment and Instrumentation Registrations in SAP and ProCal efficiently.
• Archiving.

• Managed requests for access to documentation, maintaining confidentiality.
• Resolved issues related to documentation and associated information.
• Organised, filed and stored electronic and physical files to maximise traceability.
• Coordinated Electronic Document Management System (EDMS) with strong technical knowledge.
• Carried out secure destruction and disposal of sensitive documents.
• Trained team in document control and records management best practices.
• Handled incoming correspondence and technical information, distributing as directed.
• Liaised effectively and efficiently with an outsourced IT specialist and Printer company.
• Organised workspaces for new and existing employees with computer, monitors and associated cabling or equipment.
• Requested new user account creation and managed permissions and security settings across various software applications.
• Created and managed a file to track new and ongoing support tickets and documented actions.

• Compile and distribute project status reports for enhanced transparency and accountability.
• Update project documentation, providing accurate and accessible information for Steering Group and Stakeholders.
• Submit proposal requests and tender documentation on the eTenders platform according to legal guidelines.

• Compose, update and maintain critical documentation such as Standard Operating Procedures (SOP's), Batch Records, Protocols, and Specifications.
• Ensure compliance with regulatory requirements, industry standards, and Good Documentation Practices (GDP) in all documentation.
• Collaborate with cross-functional teams to gather and organize information, creating accurate and comprehensive documentation.
• Conduct quality checks to ensure error-free documentation and adherence to company guidelines.
• Manage filing and storage of electronic and physical documentation to ensure easy retrieval and traceability.
• Support document control processes, including document revision, approval, and distribution.
• Assist in training employees on documentation procedures and best practices.
• Continuously improve documentation systems and processes to enhance efficiency and accuracy.
• Remain updated with industry regulations and guidelines related to documentation practices.

• Maintain all relevant artwork projects within the electronic artwork management system, ensuring tasks are setup, progressed, and completed on time. Carry out artwork approvals, proofreading, and printer's proofs verification checks on the digital comparator if applicable.
• Manage projects, and change controls for Artwork Changes ensuring supply continuity and business growth.
• Review and coordinate Artwork action items in the Change Control to ensure these are properly documented and closed out in line with set timelines.
• Work with cross-functional project teams and the manufacturing vendor on development for new products, new markets, and/or changes to existing printed packaging components.

• Served as a single point of contact for regulatory and supply chain artwork and packaging change requests.
• Managed all artwork and packaging change requests and implementation timelines for multiple regions.
• Ensured manufacturing engineering change requests were reviewed, approved and completed right first time to meet regulatory implementation requirements.
• Supported supply chain with material master set up and product discontinuation.
• Reported KPI's for assigned region.
• Adhoc departmental projects.

• Created and implemented processes relating to document control in accordance with ISO1348:2016 standards.
• Created and maintained a master document register for all live documents on site.
• Issued document control numbers to create or update new or existing documents.
• Reviewed and processed internal document changes on QMS and or SAP.
• Uploaded data files on SAP to generate process orders.
• Generated and edited standardised document templates.
• Provided GDP and GMP training onsite.
• Carried out internal audits onsite.
  
  

• Created and circulated internal documentation to generate artwork codes for artwork creation.
• Raised artwork codes on SAP according to internal documentation.
• Coordinated product information to create artwork right first time.
• Managed the revision of artwork right first time.
• Liaised with company regulatory departments globally.
• Manual proofing and proof reading.
• Raised internal purchase orders for artwork origination costs.
• Updated internal standard operating procedures.
• Ensured work was compliant and conformed to company cGMP, cGLP, SOP, component specification and regulatory affairs standards.
• Liaised efficiently and effectively with customers worldwide, external print vendors and across all levels of the organisation.

Internal company project to migrate paper based training record information to SAP.

• Maintained and updated the company website and customer database.
• Set up and hosted software informational seminars throughout Ireland.
• Rebranded and redesigned the company logo and website.
• Created, edited and released company press releases.
• Increase website traffic through search engine optimisation.

• Created, edited and processed informational emails using HTML or Plain Text.
• Compiled customer specific data files according to informational emails and hard copy mailings.
• Raised purchase orders to cover mailing costs.