IT-Supporter Onsite 2nd Level (m / f / x)

Assisting in the expansion and maintenance of the Quality Management System, including future certification and accreditation responsibilities.

Performing internal audits in accordance with GCLP, GCP and GLP guidelines.

Participating in audits of external customers and regulatory agencies.

Participating in qualification of equipment, systems, and suppliers.

Organizing and overseeing employee training.

Creating, revising, and reviewing documents such as SOPs and work instructions.

CAPA, deviation, risk analysis and change control management.

Active participation in quality assurance of ongoing laboratory and data analysis processes.

Creation and review of qualification and validation documents.

Job Requirements

1. Completed scientific studies in biology, biotechnology, medicine, pharmacy or comparable natural / biological sciences.
2. Experience in quality assurance, preferably in the field of biotechnology or pharmacy.
3. Knowledge of current international regulations for GCP / GLP; direct experience would be an advantage.
4. Experience with accreditation / certification procedures for GLP or in the DIN-EN-ISO field desirable.
5. Experience with computer-based system validation and cloud-based IT systems is an advantage.
6. Very good knowledge of written and spoken English is mandatory; very good knowledge of German is an asset.
7. Strong quality awareness and ability to apply quality knowledge in practical work.
8. Integrity, commitment, and a motivated work ethic.
9. Ability to work in a team and independently.

We Offer

1. Responsible and varied tasks in a motivating working environment.
2. A permanent position in a dynamically growing international life science group with over 200 employees.
3. Optimal induction and training opportunities as well as individual development options.
4. Appreciation, openness and respect as well as a lively feedback culture.
5. Flat hierarchies, short decision-making processes and flexibility.

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