Melani García Email & Phone Number

Dublin, Leinster, Ireland

Main responsibilities:• Preparation of submissions including; life-cycle maintenance variations and initial MAAs, Artwork labelling updates, renewals, marketing authorisation transfers. Preparation and reviewing regulatory documentation for DCP, MRP, CP and National licences. • Maintaining good communication and working relationship with other departments and liaising with enforcement regulatory bodies: DAFM, FSAI, EMA, EU & UK Regulatory Agencies.• A clear understanding of cGMP requirements for manufacturing, quality systems and compliance.• Regulatory compliance activities such as Change controls, Deviations, Packaging Specifications, PQRs and SOPs writing and reviewing.• Creation/Reviewing of SDS in compliance with CLP and EU Regulations.• Reviewing of Non medicinal/Nutritional products labeling to be in compliance with Feed & Food Regulations.• NPD Innovation in Nutrition & Continue Improvement projects.• Regulatory Intelligence: Maintaining and reviewing of Animal Health, Food and Feed legislations to provide appropriate guidance and minimise impact to the business.

Ireland

Main Responsibilities:• Creation/review of product labels for feed and food products according to EU/UK and local regulations.• Liaising with enforcement bodies and trade associations including EFSA, FSAI, DAFM, HPRA, FEFANA, BAFSAM.• Labelling translation, coordination and liaising with other deparments such as: QA, SupplyChain, H&S, Operations, R&D to ensure compliance.• Ongoing project management for generation of Contract Manufacturing product support documentation.• Preparing/reviewing Safety Data Sheets, Product Specification Sheets, Technical Data Sheets, SOPs review, Laboratories Analysis reports (GMOs, COAs, Undesirable Substances),• Preparation of Claims Substantiation Dossiers and reviewing and editing marketing support material.• Responsible for product dossier preparation and submission for EMEA and CIS countries, registration of new products and renewals.• EHS: Member of the Sustainability Committee.

Ireland

Main Responsibilities:• Perform routine review of documentation such as NCRs, logbooks, SOPs. Analysis reports such as COAs, COCs and certifications.• Quality check of stock, RMAs and product shelf life extensions, product recall.• Conducting Internal audits for FAMI-QS, UFAS and ISO:14001 certifications.• Investigate NCRs, customer complaints, Report audit findings and implement appropriate CAPAs.• Review and maintenance of the Quality Management System and creation of a HACCP Plan.

• Responsible for second level Quality Control procedures in order to optimize data accuracy as well as verification and data validation information on Google Maps.• Decisions making regarding accuracy from multiple sources of data choosing the best possible available for customers increasing their Google usage experience. • Using logical thinking, attention to detail and independent decision.• EHS: Sustainability and Recycling Awareness Project

Dublin, Ireland

- Provide technical assistance and support to customers.- Troubleshooting Google Wallet transactions (claims, refunds, purchases…).- Identifying and investigating customer claims and providing them with the appropriate solutions, root/cause analysis.- Serve as primary support liaison between company and customers. Understanding of customer priorities and identify key improvement areas.

Dublin

IPFN (Irish Phytochemical Food Research Network) project. Main responsibilities:- Surveying of pectins in thermally treated samples quantify pectins and carrying out the analysis of polyacetylenes, carotenoids and texture analysis.- Novel non-thermal treatment of food samples.- Quantifying Total Phenolic Content, Total Flavonoid Content, Antioxidant Assay (DPPH & FRAP), and Phenolic Profiling by LC or LC-MS of barley.- Sample analyses by LC/MS, UV/VIS, HPLC and GC.- Assay method development, validation, and report writing.- Set-up and troubleshooting of HPLC.

Almería, Spain

Main activities and responsibilities:- Quality System’s audits to ensure compliance looking for root/cause analysis, identifying key improvement areas, CAPAs (prevent and resolve any deviations and NCRs).- Consultancy and implementation of Management systems at: ISO 14001, ISO 9001/EFQM, Food Safety management ISO 22000 (Food Safety, HACCP, GMP), OHSAS 18001, ISCC.- Keep and ensure the quality of a product or a service to a consistently high standard by setting up and operating a series of checking procedures.

Dublin

Research in the Food Bioscience department, IPFN (Irish Phytochemical Food Research Network) project. Main responsibilities:- Working with a novel accelerated solvent extraction (ASE) and HPLC quantification of food bioactive compounds.- Carrying out purification techniques: solid phase extraction (SPE) and flash chromatography. - Sample analyses of samples by LC/MS, UV/VIS, HPLC and GC.- Assay method development, validation and report writing.- Set-up and troubleshooting of HPLC and LC/MS-MS systems.- QMS, GLP, GDP & GMP.

Almería, Spain

- Language Training: Intermediate and Business English- Microsoft Office package (Outlook, Excel, Access, PowerPoint, Word)- Project Manager Skills - Entrepreneurship Training - Career Guidance - Health & Safety training

Rodalquilar, Almería

- Identification and Monitoring: Plant systematics, floristics, inventories, surveys, population trends and threat factors etc.- In situ Conservation: Development, designation, care and management of protected areas, habitat restoration or re-creation and wild-plant population research, recovery or management.- Ex situ conservation through the development and maintenance of germplasm collections including seed banks, field genebanks, tissue collections in culture, individual species recovery programmes, databanks.- Public education and developing environmental awareness, including programmes to promote public understanding of biodiversity, its importance and loss.- Research and Training in many relevant fields, such as taxonomy, ecology, biochemistry, ethnobotany, education, horticulture, plant anatomy, biogeography.

Msc Food Safety Management

Activities and Societies: - Master Thesis: Design & Implementation of documented food safety systems in a Bakery based on HACCP principles.

Master'S Degree (5 Years), Environmental Science

Environmental And Agricultural Science

Erasmus programme in Unicatt - Sede di Piacenza