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Sandra Guzzetta is listed as Empathetic Team Leader | Pharmaceutical Artwork, Labelling & Packaging Expert | Passion for Process Improvement at Hapa AG, a company with 141 employees, based in Volketswil, Zurich, Switzerland. AeroLeads shows a matched LinkedIn profile for Sandra Guzzetta.
Sandra Guzzetta previously worked as Product Owner Graphics Chain Automation • Product Management at Hapa Ag and Lead Expert Packaging & Labeling / Consultant at Gerresheimer.
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PERSONAL PROFILEAmbitious, motivated and flexible expert in artwork, labeling and packaging design with 24 years of experience in a GMP and FDA regulated industry (Pharmaceutical & Medical Device Industry).18 years of experience in Artwork Leadership, Packaging & Brand Design.22 years within the Commercial Pharmaceutical Industry, 2 within Clinical SuppliesExcellent understanding in introducing of new products from prototype to commercialization, Design & Packaging Development, Change/Processes/Vendor Management, Product Management, IVDR, MDR, Regulatory Affairs & Medical Device Regulations.Excellent written and spoken German, English, Italian and French.The ability to finalize several simultaneous projects on time is one of the more gratifying aspects of my Packaging Design and Project Management careers. The feedbacks I received also highlighted that one of my strongest skills lies in excellent interpersonal and verbal communication, empathy, conflict resolution and emotional intelligence.Former functional responsibility included project leadership, launches of packaging systems, change implementations to packaging design, prepare and coordinate submissions to Swissmedic, assuring compliance to regulatory requirements and Master Data Management, Product Lifecycle Management and compiling Design Control documentation to contribute to a high quality Design History File. Medical technology standard experience in Medical Devices Directive (MDD) 93/42/EEC,Biological Evaluation of Medical Devices ISO 10993, Quality System Regulation 21 CFR 820 & ISO 13485 (Quality Management systems for Medical Devices), Packaging Validation ISO 11607, Risk Management EN ISO 14971QC experience: around 10’000 reviews of medical device / instrument labels (e.g. IFUs, Surgical Technique guides) compared to technical drawings for input to CAPAs / Field Action (QA), Quality control of reviews & conformity to Medical Devices Directive, Essential Requirements for CE-marking (symbols, pictograms, etc.)
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Volketswil, Zürich, Schweiz
Spearhead the integration of pharmaceutical artwork expertise into software solutions designed for Hapa printing machines.Act as the primary liaison between product management, software developers, engineers, and customers to align artwork workflows with printing technology and engineering requirements.Define and prioritize product features and.
Olten, Solothurn, Schweiz
Global Process Lead - Completion of the packaging and Labeling process with the aim to achiveve Legal Manufacturer Sensile MedicalGlobal Process Owner for E2E Labeling Process – provide decisions required and oversight to Process Leads (PL), accountable to drive initial process optimization and responsible to sustain and drive continuous improvement.
Baar, Zug, Schweiz
Lead the team of 13 Labeling CoordinatorsGlobal Labeling strategy: oversee Labeling strategy and tactical advice to teams to achieve timely, efficient, and compliant development and maintenance of Labeling documents Global Process Owner for E2E Labeling Process – provide decisions required and oversight to Process Leads (PL), accountable to drive initial.
Rotkreuz
Support of Regulatory Affairs related activities of the DQDAA team for the implementation of the IVDR requirements:- Creation of relevant templates- Align, if necessary, the defined approach with the relevant functions and other regulatory teams- Communicate the progress to the relevant functions and committees- Provides regulatory support to the relevant.
Baar, Zug, Schweiz
Responsible for coordinating artwork changes to printed components through the international change management process. The processes include the development of and changes to the printed components used within the Biogen and CMO Label & Packaging facilities Coordinate artwork product development for launch project and lifecycle management on behalf of the.
Luzern Und Umgebung, Schweiz
Creation of label text translations using a translation database and authorization of translations in terms of study-specific, internal company and country-specific regulatory requirements.Create and monitor the project schedule and coordinate projects of the label text translation to the delivery of labels to the packaging department.Ensures through.
Bern Und Umgebung, Schweiz
Responsible for the implementation of new and updated Company Core Data Sheet’s (CCDS’s) of CSL Behring products in the regional/local labelling of the assigned Region within the set timeframeInteracts with relevant stakeholders like the CCDS owners, the points of contacts in the Region boundaries, and local commercial organizations, as applicableEnsures.
Basel Und Umgebung, Schweiz
Responsible for the generation, distribution and archiving of released certificates of analysis adapted for regulatory purposes.Prepares and edits certificates of analysis for regulatory purposes according to instructions and requirements from internal customersManages independently priorities of requests received and ensures timely delivery of documents.
Zuchwil
Project was finalized on time by the end of December 2014Acting as a reviewer of label and labelling material (package label, Instructions for Use, Technique Guides) in order to:Assure consistency of labelling contentIdentify and document inconsistenciesAllocating of records to corresponding articles in close collaboration with Product Development.
Other employees you can reach at hapa.ch. View company contacts for 141 employees →
Max Braun
Colleague at Hapa AgGreater Hamburg Area, Germany
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Stefan Braun
Colleague at Hapa AgMönchaltorf, Zurich, Switzerland, Switzerland
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Luca Patrizio
Colleague at Hapa AgVolketswil, Zurich, Switzerland, Switzerland
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Kevin Kuster
Colleague at Hapa AgHerisau, Appenzell Outer-Rhoden, Switzerland, Switzerland
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Yuanyuan(Helen) Zhou
Colleague at Hapa AgSwitzerland, Switzerland
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Dr.-Ing. Ralf Bomhauer-Beins
Colleague at Hapa AgUster, Zurich, Switzerland, Switzerland
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Tilman Steinmetz
Colleague at Hapa AgZurich, Switzerland, Switzerland
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Birgitta Marty
Colleague at Hapa AgVolketswil, Zurich, Switzerland, Switzerland
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Sven S.
Colleague at Hapa AgZurich, Zurich, Switzerland, Switzerland
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Magdalena Rot
Colleague at Hapa AgVolketswil, Zurich, Switzerland, Switzerland
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Quick answers generated from the profile data available on this page.
Sandra Guzzetta works for Hapa AG.
Sandra Guzzetta is listed as Empathetic Team Leader | Pharmaceutical Artwork, Labelling & Packaging Expert | Passion for Process Improvement at Hapa AG.
Sandra Guzzetta is based in Volketswil, Zurich, Switzerland while working with Hapa AG.
Sandra Guzzetta has worked for Hapa Ag, Gerresheimer, Medela, Roche, and Biogen.
Sandra Guzzetta's colleagues at Hapa AG include Max Braun, Stefan Braun, Luca Patrizio, Kevin Kuster, and Yuanyuan(Helen) Zhou.
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