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Manager Clinical QA (f/m)

As an international family business of the plasma industry, we are proud of this: our products save lives. We have strong European roots and are growing continuously. Therefore, we are looking for:
 
Manager Clinical QA (f/m)
Clinical R&D

Your tasks are diverse – from supporting continuous improvement of Clinical R&D to perform Clinical study audits. This includes:

  • Identify compliance weaknesses and work with staff to identify possible root cause and
  • develop effective corrective and preventive action plan
  • Manage the CR&D training program
  • Perform QC review of clinical documents
  • Ongoing quality support to CR&D staff and provide QA input to special projects in CR&D as necessary
  • Organize and perform clinical study audits (at study sites, CROs and contractors)

What we expect?

  • University degree (preferably medical or biosciences)
  • At least 5 years experience in the Pharmaceutical or CRO Industry, preferably in Clinical Operations
  • Good clinical knowledge with an understanding of medical terminology
  • Excellent English
  • Solid understanding of applicable guidelines and regulations for clinical studies
  • Experience in quality management desirable (certified quality manager and quality auditor)
  • Strong analytical, problem solving skills with excellent written and verbal communication skills
  • Strong organisational, presentation, documentation and inter-personal skills
  • Willingness to travel (travel time up to 50%)

What we offer?

  • Versatile tasks in an international environment, flexibility and self-responsibility
  • Familiar surroundings of a family business with benefits such as Do & Co company restaurant and exceptional employee events
  • Reliable employer with generous social benefits and marketable payment. The basis for this position: Collective agreement for employees of the Chemical industry VG IV (€ 3,065.25)

Do you want to become a member of the Octafamily? We look forward to receiving your application:

octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien,
Mag. Werner Mikschicek
T: +43 (1) 610 32 – 1303, www.octapharma.com