Simona Chiesa Email and Phone Number
After earning a Master's degree in Industrial Biotechnology, I started working as Quality Assurance for pharmaceutical industry, and now I gained 7 years of experiece in the pharaceutical sector.In the last year I have been dealing with the manufacturing trasfer of pharmaceutical aerosol valves and spray pumps from the company Coster s.p.a. to the new born company RxPack s.r.l.My area of expertise:- Batch record and quality review;- Deviations and claims management;- CAPA and Change Control management;- Editing of Production and QA procedures, product specifications, master batch records;- Process validation;- Promote the meeting of quality/regulatory expectations of new pharmaceutical customers;I’m a reliable and professional person, with good communication skills and able to work both in team and autonomously.
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Quality Assurance Specialist And Regulatory AssistantRxpack Jun 2021 - PresentSupport the Quality unit during the manufacturing transfer of pharmaceutical aerosol valves, spray pumps and actuators from Coster group to new RxPack company (50% VARI - 50% Coster ownership, with full manufacturing in ex-VARI site):- constant communication with Coster Quality unit to collect all the relevant documentation related to product's Quality and manufacturing- integration of Coster product's documentation in RxPack QMS: issue of Quality Specification, Test Methods, Control Plan, List of defects, manufacturing instructions, Packaging specifications- definition of Quality Agreements with suppliers- compiling of customer's product questionnaires- collection of Regulatory info/certificationsTake advantage of the experience in the pharmaceutical sector to promote the meeting of Quality/Regulatory expectations of new pharmaceutical customers -
Quality Assurance SpecialistTeva Active Pharmaceutical Ingredients Jan 2018 - May 2021Bulciago, Lombardia, ItaliaAIFA and FDA inspected. Main responsabilities:- Batch Record review.- deviations management (production and warehouse)- Quality Walk Around on shop floor- Update of QA and production procedures.- Update of Master Batch Record.- Process Validations- Product Quality Review.- CAPA and Change Control Management- Claims management support -
Documentation Quality AssuranceBaxter International Inc. Jul 2016 - Dec 2017Sondalo, Lombardia, ItaliaAIFA and FDA inspected.Main responsability: implementation of product labeling changes- R&D Artwork Evaluation- Supplier's draft approval- Change Control Management- Coordination of the involved functions (Regulatory Affairs, Supply Chain, Production Planning, Warehouse, Engigneering) -
Intern Customer ServiceTapi - Teva Active Pharmaceutical Ingredients Sep 2015 - Feb 2016Bulciago( Lc)Update of Customer Service documentation (Product Questionnaire and Statement) and documentation management with CRM Software.
Simona Chiesa Skills
Simona Chiesa Education Details
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Biotecnologie
Frequently Asked Questions about Simona Chiesa
What company does Simona Chiesa work for?
Simona Chiesa works for Rxpack
What is Simona Chiesa's role at the current company?
Simona Chiesa's current role is Quality Assurance Specialist in pharmaceutical sector.
What schools did Simona Chiesa attend?
Simona Chiesa attended Università Degli Studi Di Milano-Bicocca, Università Degli Studi Di Milano-Bicocca.
What skills is Simona Chiesa known for?
Simona Chiesa has skills like Customer Experience, Software Siebel Crm, Good Manufacturing Practice, Microbiologia Industriale, Colture Microbiche, Chimica Delle Fermentazioni, Microscopia, Spettrofotometria, Hplc, Dosaggi Enzimatici, Biologia Molecolare, Pcr.
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