Coordinator Quality Management / Regulatory Affairs

- part time 20-25 h/week -

Our client is a leading operating biopharmaceutical enterprise with a presence in more than 70 countries. We are searching as soon as possible for at minimum 6 months a dedicated 

Coordinator Quality Management / Regulatory Affairs

- part time 20-25 h/week -

  • Bereich:

    Interim- & Contract Management

  • Berufssparte:

    Qualitätswesen/Qualitätsmanagement

  • Arbeitsregion:

    Großraum München

  • Art der Anstellung:

    Permanent

  • Kennziffer:

    25544

  • Aktualisierung:

    07.10.2019

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Your tasks

Coordinator Quality and Regulatory Management

  • Document management (electronic and hard copy) for Quality Management and Regulatory Affairs
  • Organization of meetings, events and telephone conferences
  • Support in budget planning/LE process/invoice processing
  • General administrative support

 

Quality Management and complaint handling

  • Assist Quality Team in all relevant quality activities
  • Support Quality Team to ensure a timely complaint handling of customer complaints
  • Support in local processing of Product Quality complaints
  • Assist in maintaining training documentation
  • Support in archiving documents

 

Regulatory Affairs

  • Assist in creating or changing of print version of the SmPC and “Rote Liste”
  • Supports the Regulatory Team in all regulatory activities

Your qualifications

  • Proven experience as Assistance, preferentially within pharmaceutical industry with knowledge on Good Distribution Practice and Regulatory Affairs
  • Structured, proactive and highly dependable
  • Strong financial/budgeting skills
  • A strong commitment to quality and patient safety
  • A good understanding of internal customer needs and project needs
  • Fluent German and good English skills (verbal and written)
  • Proficient in Microsoft Office (Word, Outlook, Excel, PowerPoint)

Ihr Ansprechpartner

Bettina Cöppicus
Senior Personalberaterin

Anschrift

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