Daniela D.
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Daniela D. Email & Phone Number

Qa Validation Coordinator at Alfasigma
Location: Italy 3 work roles 5 schools
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Current company
Alfasigma
Role
Qa Validation Coordinator
Location
Italy
Company size
1192 employees

Who is Daniela D.? Overview

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Quick answer

Daniela D. is listed as Qa Validation Coordinator at Alfasigma, a with 1192 employees, based in Italy. AeroLeads shows a matched LinkedIn profile for Daniela D..

Daniela D. previously worked as Quality Assurance Specialist at Menarini Group and QA Contract Manufacturing at Novartis Vaccines & Diagnostics Srl. Daniela D. holds Master Of Advanced Learning, Drug Design And Synthesis, Siena University, Post Graduated Degree from Università Degli Studi Di Siena.

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Alfasigma

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Profile bio

About Daniela D.

14 years in Quality Assurance with a demonstrated history of working in the pharmaceuticals industry.Managing a 6 persons team. Skilled in Verification and Validation (V&V), Pharmaceutics, Good Manufacturing Practice (GMP), Cleaning Validation activities, Media Fill, Cross contamination . Managing health authorities and clients audits. Strong quality assurance professional.

Listed skills include Gmp, Sop, Capa, Quality Auditing, and 31 others.

Current workplace

Daniela D.'s current company

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Alfasigma
Alfasigma
Qa Validation Coordinator
bologna, emilia-romagna, italy
Website
alfasigma.com
Employees
1192
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3 roles

Daniela D. work experience

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Qa Validation Coordinator

Current
Alfasigma

Management of qa validation team (6 persons): Process Validation, Filter validation, Cleaning Validation, Cross Contamination, Media Fill, PQR, Sterility assurance, ICHQ3D

Apr 2019 - Present

Quality Assurance Specialist

Menarini Group

L’Aquila Area, Italy

Handling of Quality Assurance activities related to pharmaceutical oral solid dosage forms.Quality risk management application:Validation life cycle:• Process Validation (PV protocol and related report drafting, sampling activities performing, support to equipment qualification)• Cleaning Validation (Cleaning Validation Plan. PDE skilled, Cleaning validation protocol and related report drafting, sampling activities performing, Cleaning SOP for equipments and rooms drafting)Quality management:• GMP audit direct involvement (Health authority [AIFA, ANVISA, Taiwan FDA] and third parties)• Auditor at Internal audit (Self inspection) and third parties audit• Raw material (API and packaging materials) suppliers qualification (quality questionnaire evaluation, audit report evaluation by QA perspective, QA approval of the supplier)GMP documentation system:• SOP drafting and revising• GMP documentation creating, issuing and revising • Risk analysis related to Change Request / audit deficiency • Batch Record Review• Handling of CAPA • Handling of Supplier compliant • Handling of customer compliant (Trackwise system)• Support to Complaint, change request, deviation management activities• KPI related to QA activities Training:• Training management

Sep 2010 - 2019

Qa Contract Manufacturing

Novartis Vaccines & Diagnostics Srl

Siena

Provide support to Departement activities related to:Contract manufaturer qualification according to GMP, Quality Agreement drafting, Batch Record review, Approval flow of the documentation used by third parties.Distributors qualification, issue and revision of quality survey, evaluation of the risk related to distributors, QAG drafting.

Sep 2009 - Jul 2010
Team & coworkers

Colleagues at Alfasigma

Other employees you can reach at alfasigma.com. View company contacts for 1192 employees →

OM Oussama Mabrouk Oussama Mabrouk Colleague at AlfasigmaMonastir, Tunisia View → CS Catalin Stroe Catalin Stroe Colleague at AlfasigmaConstanţa, Romania View → DG Domenico Gulluscio Domenico Gulluscio Colleague at AlfasigmaMontalto Uffugo, Calabria, Italy View → AF Alessandro Fabrizi Alessandro Fabrizi Colleague at AlfasigmaGuidonia Montecelio, Latium, Italy View → AC Anna Canepa Anna Canepa Colleague at AlfasigmaGenoa, Liguria, Italy View → TB Tonino Bentivoglio Tonino Bentivoglio Colleague at AlfasigmaGreater Milan Metropolitan Area, Italy View → LR Leticia R. Leticia R. Colleague at AlfasigmaValencia, Valencian Community, Spain View → KV Karen Van Diest Karen Van Diest Colleague at AlfasigmaThe Randstad, Netherlands View → VR Véronique Ripoll Véronique Ripoll Colleague at AlfasigmaHeyrieux, Auvergne-Rhône-Alpes, France View → SV Stefano Volpe Stefano Volpe Colleague at AlfasigmaPescara, Abruzzi, Italy View →
5 education records

Daniela D. education

Master Of Advanced Learning, Drug Design And Synthesis, Siena University, Post Graduated Degree

Università Degli Studi Di Siena

Activities and Societies: Drug design, drug optimization, bioinformatichttp://www3.unisi.it/did/master-dds/2009-2010/programma.htm

Dissertation Intership, Role Of The Cannabinoid Recepetors In The Atherosclerosis Pathogenesis

Center For Excellence On Ageing (Cesi) Chieti

http://www.crc-cesi.org/

FAQ

Frequently asked questions about Daniela D.

Quick answers generated from the profile data available on this page.

What company does Daniela D. work for?

Daniela D. works for Alfasigma.

What is Daniela D.'s role at Alfasigma?

Daniela D. is listed as Qa Validation Coordinator at Alfasigma.

Where is Daniela D. based?

Daniela D. is based in Italy while working with Alfasigma.

What companies has Daniela D. worked for?

Daniela D. has worked for Alfasigma, Menarini Group, and Novartis Vaccines & Diagnostics Srl.

Who are Daniela D.'s colleagues at Alfasigma?

Daniela D.'s colleagues at Alfasigma include Oussama Mabrouk, Catalin Stroe, Domenico Gulluscio, Alessandro Fabrizi, and Anna Canepa.

How can I contact Daniela D.?

You can use AeroLeads to view verified contact signals for Daniela D. at Alfasigma, including work email, phone, and LinkedIn data when available.

What schools did Daniela D. attend?

Daniela D. holds Master Of Advanced Learning, Drug Design And Synthesis, Siena University, Post Graduated Degree from Università Degli Studi Di Siena.

What skills is Daniela D. known for?

Daniela D. is listed with skills including Gmp, Sop, Capa, Quality Auditing, Quality Assurance, Audit, Process Validation, and Cleaning Validation.

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