Drug Safety Quality Assurance Associate

Vor 5 Tagen

Wien, Österreich Octapharma Pharmazeutika Produktionsges.m.b.H Vollzeit

**Stellen-ID**:55523

**Standort**:Wien, AT

**Karrierestufe**:Professionals

**Fachbereich**:Drug Safety

**Beschäftigungstyp**:Permanent position

Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are now hiring for our team:
**Your new challenges which will inspire you**:

- Assistance in the implementation and maintenance of a comprehensive GVP compliant quality program
- Maintenance and development of the Octapharma drug safety SOP system
- Assistance with the initiation, writing, review, approval, update, and distribution of documents e.g. policies, SOPs, and associated documents
- Maintenance and development of the Octapharma drug safety training system
- Maintenance and development of the Octapharma drug safety deviation management system and CAPA plan
- Training and ongoing qualification of local drug safety personnel
- Management of external safety relevant network
- Compliance and deviation management of the drug safety system at Octapharma
- Development and maintenance of the Octapharma Pharmacovigilance System Master File
- Preparation, execution, post-processing of authority PV inspections, preparation of inspection report and coordination of action plans
- Planning, conduct and follow up of drug safety audits

**Your profile that will convince us**:

- Completed academic degree, ideally in a medical, life science or healthcare discipline
- Pharmacovigilance knowledge and experience in quality assurance related to drug safety would be an advantage
- Working knowledge of GVP, GCP and ICH and how they interface with other GxPs
- Very good verbal and written English skills as well as communication and presentation skills
- Team player with a strong focus on timelines
- Good level of computer literacy, in particular in the use of databases
- Commitment and ability to handle high workloads and deadlines
- High degree of accuracy with attention to detail
- Excellent critical, analytical and problem-solving skills

**Our attractive benefits for you**:

- Wide range of tasks in an international setting, flexibility and personal responsibility
- Reliable employer with generous employee benefits and a salary customary in the market.
- Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more:
**Additional information**:
The minimum gross salary according to the collective agreement (chemical industry) for your new job is EUR 3.909,67. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay salaries higher than collectively agreed.

**Your contact**:
Mag. (FH) Charlotte Ponzer
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien
T: +43 (1) 610 32 - 1301

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