Global Quality Product Manager
March 2014 to Present
Milan Area, Italy
Head of technical registration documentation
January 2011 to Present
Development Documentation Manager
November 2007 to December 2010
Quality organization manager
April 2002 to November 2007
Cosmo pharmaceuticals S.p.A-
Analytical development manager
May 2001 to April 2002
What company does Stefania Conta work for?
Stefania Conta works for Grünenthal
What is Stefania Conta's role at Grünenthal?
Stefania Conta is Global Quality Product Manager
What industry does Stefania Conta work in?
Stefania Conta works in the Pharmaceuticals industry.
Global Quality Product Manager @ Reporting to the Global QA CMC Director. Main responsability: From March 2014 to Present (1 year 10 months) Milan Area, ItalyHead of technical registration documentation @ Reporting to the QP and GMP QA director. Main responsability: • support for new local and global projects development through raw data/ documents review and technical support (e.g. analytical validation, process validation, stability specifications, ASMFs); • support for all new and ongoing regulatory procedures • compilation of new CTD dossiers • preparation of responses to Dls; • compilation of the variations package necessary for change implementation. • review of master document (e.g. batch record, specifications, analytical procedure) to assure regulatory compliance From January 2011 to Present (5 years) Development Documentation Manager @ From November 2007 to December 2010 (3 years 2 months) Quality organization manager @ Main duties: • Ensure all GMPs, SOPs and protocols are followed • Manage and control the documentation regarding Quality System • Review batch documentation for accuracy and completeness according to ensure timely release • Manage deviations and non conformances; customers and supplier complaints; change control system; CAPA; Quality Agreement; Annual product review • Conduct periodical self inspection • Organiza training of all the employees From April 2002 to November 2007 (5 years 8 months) Analytical development manager @ Responsible for new incoming projects and of lifecycle changes for existing products - analytical transfer (protocol & report) - analytical validation (protocol & report) - stability studies according to ICH to support new marketing authorization or variation submission - photostability/forced degraation studies/in-vitro dissolution comparison From May 2001 to April 2002 (1 year) Laurea, Chimica e tecnologie farmaceutiche, 110/110 @ Università degli Studi di Milano From 1986 to 1991 maturità scientifica, 58/60 @ Liceo scientifico Vittorio Veneto Milano From 1981 to 1986 Stefania Conta is skilled in: Pharmaceutical Industry, Regulatory Submissions, Regulatory Requirements, Regulatory Affairs, GMP, Sop, Pharmaceutics, Drug Development, Clinical Trials, Pharmacovigilance, Market Access, Clinical Development, GCP, FDA, Biotechnology, CTMS, Teamwork, Analytics, ICH-GCP
Extraversion (E), Intuition (N), Feeling (F), Judging (J)
3 year(s), 4 month(s)
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