Anna Mccarthy Email & Phone Number

Carrigtwohill, Cork, Ireland

Ida Business & Technology Park, Carrigtohill, Cork

Ensure that packaging artwork and documentation meet Regulatory Authority, legal, and manufacturing requirements and corporate branding standards.Manage projects throughout life-cycle from Regulatory Affairs Variation Approval and Request, through to generation of Change Control and Document Change Order for component specification documentation and MES/Oracle Bill of Materials implementation.Strong co-ordination and communication with external suppliers, International Regulatory Affairs, local market Regulatory Affairs, Graphic Designers, Packaging Engineering, Quality Control, Quality Assurance, Validation and Supply Chain ensuring projects are implemented within Regulatory deadlines.Work closely with RA colleagues across Europe, Australia and Asia, QA, and Supply Chain to meet project deliverables ensuring compliant packaging and uninterrupted commercial product supply.Support introduction of new products on site, by prioritising projects in accordance with EU Product Launch Plans.Develop, review and co-ordinate approval of commercial labeling for international markets, in more than 20 languages, across the Latin, Cyrillic, Greek, & Hangul alphabets. Creation and revision of specifications and associated documentation for the introduction or revision of each new packaging component.Support maintenance of the Packaging Validation Matrix with the revision of each packaging component and with the product launch of each new market specific pack.Provide input and support to the Corrective and Preventive Action programme (CAPAs).Support of the Internal Audit, Vendor Audit and Regulatory Audit Programmes.Consistently adhere to cGMP and Standard Operating Procedures and assist in the training of other team members.Proficient in PC & MAC; MS Office, Adobe Illustrator, Adobe InDesign, Adobe Acrobat, MES, Oracle, Agamik Barcoder, EQMS: CAPA and Change Control.

Touchdown Business Park, Cork, Ireland

Employed by PrintWorks, a leading in-house manufacturer of labels and packaging, as Operations Manager responsible for day to day performance of a manufacturing facility.

Little Island, Cork, Ireland

Cork, Ireland

Turners Cross, Cork, Ireland