Isabel Häfner Email and Phone Number
Personality:Structured, high awareness for quality and responsibilityEntrepreneurial mindset and cross functional thinking and actingAnalytical thinking, pragmatic and highly self - motivatedTeam player and leadership abilityExperience / Reference:- Broad experience in Pharmaceutical Industry- Responsible Person / Swiss Qualified Person ("Fachtechnisch verantwortliche Person" / FvP) acc. to Swiss Health Regulation - Familiar with German, Swiss and Austrian Health Regulation- Conceptualise, Implementation and Maintenance of Quality Management System GDP / GMP- Contract and Supplier Management- Successful Health Authority Inspections- Holdership of Marketing Authorisation for Switzerland- Application for, Maintenance and Transfer of Swiss Marketing Authorisation- Product Launch- Implementation "Track and Trace" acc. Falsified Medicines Directive (DIR 2011/62/EU / DIR 2011/83/EC)- Project Management within Regulatory and Quality Affairs- Pharmacovigilance- Reimbursement- Collaboration with national Health Authorities (e.g. Swissmedic, BAG)Product groups:- Rx and OTC Products- Sterile and non sterile Products- Pharmaceuticals for therapy and diagnosis- Nuclear Medicine, Radiopharmaceuticals- Biopharmaceuticals- Synthetica- Narcotics- Phytopharmaceuticals and Homeopathics- Medical Devices
Pharma Support Gmbh
View- Website:
- ph-support.ch
- Employees:
- 1
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Consultant Quality And Regulatory And Responsible Person (Swiss Qp And Fvp)Pharma Support GmbhSteinhausen, Zg, Ch -
Consultant Quality & Regulatory / Responsible Person (Swiss Qp / Fvp)Pharma Support Gmbh Nov 2021 - PresentZug, Schweiz -
General ManagerPharma Support Gmbh Nov 2021 - PresentZug, Schweiz«Quality is not an act, it is a habit» (Aristoteles)https://www.ph-support.ch/Pharma Support GmbH supports you in the implementation and maintenance of regulatory requirements for handling of pharmaceuticals and medical devices.The core competence is services in the area of quality management and management of licenses, marketing authorisations and product registration files for Swiss marketing authorisation holders, distributors, wholesalers and logistic suppliers.Including appointments as Swiss QP / Swiss RP or Deputy
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Sr. Manager Commercial Quality Alpine / Swiss Qp (Fvp)Allergan Dec 2020 - Oct 2021Zürich Und Umgebung -
Head Quality & Regulatory DachBender Gruppe Jul 2018 - Oct 2020Zürich Und Umgebung, Schweiz / Baden-Baden, Deutschland
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Responsible Pharmacist (Swiss Qp / Fvp)B.E. Imaging Ag - Swiss Mah For Curium Pharma Jul 2018 - Oct 2020Zürich Und Umgebung, Schweiz
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Interim Management Quality & Regulatory ComplianceBausch Health Companies Inc. Apr 2018 - Jun 2018Zug (Zg), Switzerland -
Quality Assurance And Responsible Pharmacist (Swiss Qp / Fvp)Merck Gruppe Apr 2017 - Feb 2018Zug (Zg), Switzerland -
Manager Quality Assurance & Regulatory Affairs / Responsible Pharmacist (Swiss Qp / Fvp)Mallinckrodt Pharmaceuticals Sep 2013 - Mar 2017Cham (Zg), Switzerland -
Manager Regulatory Affairs And Quality Assurance (Deputy Swiss Qp / Fvp)Schwabe Group Aug 2010 - Jul 2013Küssnacht Am Rigi (Sz), Switzerland -
Regulatory Cmc & Quality ManagerAenova Group Sep 2005 - Jun 2010Kirchberg (Sg), Switzerland -
Head Of Quality ControlHänseler Ag Jul 2002 - Aug 2005Herisau (Ar), Switzerland -
Quality Control AnalystAenova Swiss Caps Apr 2000 - Jun 2002Kirchberg (Sg), Switzerland -
Area Manager Textile Outlet RetailLematex Apr 1998 - Mar 2000Albstadt Ebingen, Germany
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Project Engineer (Temporary)Daimler Benz Aerospace, Dornier Sep 1997 - Dec 1997Friedrichshafen, Germany
Isabel Häfner Skills
Frequently Asked Questions about Isabel Häfner
What company does Isabel Häfner work for?
Isabel Häfner works for Pharma Support Gmbh
What is Isabel Häfner's role at the current company?
Isabel Häfner's current role is Consultant Quality and Regulatory and Responsible Person (Swiss QP and FvP).
What are some of Isabel Häfner's interests?
Isabel Häfner has interest in Traveling, Kino, Music, Tennis, Theater.
What skills is Isabel Häfner known for?
Isabel Häfner has skills like Pharmaceuticals, Regulatory Affairs, Arzneimittelzulassung, Gxp, Gmp, Gdp, Quality Management, Quality Assurance, Quality System, Product Quality Reviews, Capa, Change Control.
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Isabel Hafner
Greater Wurzburg Area -
Isabel Hafner
Germany -
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