Qualified Person (m/f)

Our Client is a leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.

 

At our client's site in South Germany we are searching for a dedicated and highly motivated

Qualified Person (m/f)

  • Bereich:

    Medical

  • Berufssparte:

    Qualitätswesen/Qualitätsmanagement

  • Arbeitsregion:

    Eberbach, Schorndorf

  • Art der Anstellung:

    Permanent

  • Kennziffer:

    19523

  • Aktualisierung:

    24.03.2017

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Your Tasks:

  • Responsibility for the usage decision of drug batches as Qualified Person in accordance with § 14 AMG and the requirements in Annex 16 of the EU GMP Guide
  • Training as part of the Quality Unit
  • Creation of GMP declarations for active substances
  • Release of food products
  • Review of complaints

Your Qualifications:

  • Licensed pharmacist or equivalent as basic requirement to fulfill the role as QP according to regulations (§15 AMG / §14 AMG)
  • Previous Quality Assurance experience
  • Up to date understanding of regulatory expectations
  • Good written and verbal communication English skills
  • Excellent decision-making and problem solving skills

Ihr Ansprechpartner

Bettina Cöppicus
Senior Personalberaterin

Anschrift

Optares ICM GmbH & Co. KG
Bettina Cöppicus
Heiligengeist Höfe 8
26121 Oldenburg