As one of the world's leading biopharmaceutical companies, our client Takeda is committed to bringing Better Health and a Brighter Future to people worldwide. To further strengthen the local Research and Compliance team, at the site in 1220 Vienna, Takeda is seeking for a
GLP Auditor (w/m/d)
GLP Quality Systems and Compliance
- Execute protocols, study phases, raw data, amendment and final report audits of non-clinical, analytical and bioanalytical studies
- Conduction of the studies in compliance with international and domestic GLP & OECD GLP regulations (in-house and multi-site)
- Provide stakeholders with expertise for GLP quality/compliance recommended corrective actions
- Perform internal quality system inspections (process/facility/equipment/validation) and review of corresponding regulatory documentation
- Review and audit compliance documents, SOPs, and protocols in support of test facilities GLP regulated activities
- Support other quality GLP and QMS related activities as assigned
- Bachelor's degree in a scientific field
- Minimum 5 years of experience in GLP compliance/ QA in a pharmaceutical or biotech industry
- Work experience in internal/ external domestic and international GLP auditing is required
- Good knowledge of international regulatory requirements and industry guidelines for global GLP
- General knowledge of drug development process
- Ability to identify issues and offer solutions in a pragmatic way
- Excellent written and verbal communication skills in English and German to create a cooperative conversation and build relationships
- Strong in critical thinking, strategic planning and self-management
Takeda fosters a collaborative workplace, driven by integrity - one of Takeda's long-held values that extends to both the patients they serve and their employees who develop and deliver medicines.
The minimum salary for this position is € 4.439,01 gross per month (full time, collective wage agreement for the chemical industry), due to your professional experience and your qualifications an increased payment is intended. The contract will be limited for 1 year, an extension of the duration is possible.
We draw your attention to the fact that your application documents in their entirety, including all personal data contained therein, will be forwarded to Takeda for the purpose of carrying out the application procedure and the pre-selection....