Isabel Häfner

Isabel Häfner Email and Phone Number

Consultant Quality and Regulatory and Responsible Person (Swiss QP and FvP) @ Pharma Support GmbH
Steinhausen, ZG, CH
Isabel Häfner's Location
Steinhausen, Zug, Switzerland, Switzerland
About Isabel Häfner

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

Isabel Häfner's Current Company Details
Pharma Support GmbH

Pharma Support Gmbh

View
Consultant Quality and Regulatory and Responsible Person (Swiss QP and FvP)
Steinhausen, ZG, CH
Website:
ph-support.ch
Employees:
1
Isabel Häfner Work Experience Details
  • Pharma Support Gmbh
    Consultant Quality And Regulatory And Responsible Person (Swiss Qp And Fvp)
    Pharma Support Gmbh
    Steinhausen, Zg, Ch
  • Pharma Support Gmbh
    Consultant Quality & Regulatory / Responsible Person (Swiss Qp / Fvp)
    Pharma Support Gmbh Nov 2021 - Present
    Zug, Schweiz
  • Pharma Support Gmbh
    General Manager
    Pharma Support Gmbh Nov 2021 - Present
    Zug, 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
  • Allergan
    Sr. Manager Commercial Quality Alpine / Swiss Qp (Fvp)
    Allergan Dec 2020 - Oct 2021
    Zürich Und Umgebung
  • Bender Gruppe
    Head Quality & Regulatory Dach
    Bender Gruppe Jul 2018 - Oct 2020
    Zürich Und Umgebung, Schweiz / Baden-Baden, Deutschland
  • B.E. Imaging Ag - Swiss Mah For Curium Pharma
    Responsible Pharmacist (Swiss Qp / Fvp)
    B.E. Imaging Ag - Swiss Mah For Curium Pharma Jul 2018 - Oct 2020
    Zürich Und Umgebung, Schweiz
  • Bausch Health Companies Inc.
    Interim Management Quality & Regulatory Compliance
    Bausch Health Companies Inc. Apr 2018 - Jun 2018
    Zug (Zg), Switzerland
  • Merck Gruppe
    Quality Assurance And Responsible Pharmacist (Swiss Qp / Fvp)
    Merck Gruppe Apr 2017 - Feb 2018
    Zug (Zg), Switzerland
  • Mallinckrodt Pharmaceuticals
    Manager Quality Assurance & Regulatory Affairs / Responsible Pharmacist (Swiss Qp / Fvp)
    Mallinckrodt Pharmaceuticals Sep 2013 - Mar 2017
    Cham (Zg), Switzerland
  • Schwabe Group
    Manager Regulatory Affairs And Quality Assurance (Deputy Swiss Qp / Fvp)
    Schwabe Group Aug 2010 - Jul 2013
    Küssnacht Am Rigi (Sz), Switzerland
  • Aenova Group
    Regulatory Cmc & Quality Manager
    Aenova Group Sep 2005 - Jun 2010
    Kirchberg (Sg), Switzerland
  • Hänseler Ag
    Head Of Quality Control
    Hänseler Ag Jul 2002 - Aug 2005
    Herisau (Ar), Switzerland
  • Aenova Swiss Caps
    Quality Control Analyst
    Aenova Swiss Caps Apr 2000 - Jun 2002
    Kirchberg (Sg), Switzerland
  • Lematex
    Area Manager Textile Outlet Retail
    Lematex Apr 1998 - Mar 2000
    Albstadt Ebingen, Germany
  • Daimler Benz Aerospace, Dornier
    Project Engineer (Temporary)
    Daimler Benz Aerospace, Dornier Sep 1997 - Dec 1997
    Friedrichshafen, Germany

Isabel Häfner Skills

Pharmaceuticals Regulatory Affairs Arzneimittelzulassung Gxp Gmp Gdp Quality Management Quality Assurance Quality System Product Quality Reviews Capa Change Control Qualification Fda Sop Validation 21 Cfr Part 11 Pharmaindustrie Nuclear Medicine Contrast Media Phytopharmaceuticals Medical Devices Food Supplements Sap R/3

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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