Special services for pharmaceutical companies and related industries

Petra Grunenberg-Gomaa

Pharmacist

Main focus

  • Qualified Person
  • Wholesale responsible Person
  • Quality Assurance
  • Validation
  • Product Quality Review

CV

Born in Goldbach (Aschaffenburg)

1985 - 1990

Studies in pharmacy (Julius-Maximilians-University, Würzburg); practical training in a public pharmacy and Klinge Pharma GmbH (Formulation development)

1991 - 1999

Klinge Pharma GmbH, Munich; Formulation development (Solid dosage forms, Multiple units, Film coating, Process transfer / Scale-up into production scale); Clinical trial materials (Supply and coordination of study medication; data base implementation); Dosage form development

09/2003 - 06/2009

Working as free-lancer, mainly focused on Quality assurance (Product Quality Reviews), Process and cleaning validation, compilation of Development reports, german/english translations (2002-03/2004: Fujisawa Germany GmbH, since 04/2005: Astellas Pharma GmbH)

07/2009 - 09/2010

Temmler Werke GmbH, Munich: Assistant Head of bulk production (Solid and liquid products)

since 10/2010

Working as free-lancer, mainly focused on Documentation (Manufacturing Instructions), Quality assurance (Product Quality Reviews), Process and cleaning validation

since 06/2013

PharmaSupport
Interim management e.g. Qualified Person, Head of Production, Wholesale responsible Person