Scientist Regulatory Compliance
vor 2 Wochen
For our client in Bern, Modis is currently looking for a Scientist Regulatory Compliance with a temporary contract until 31.12.2023.
General Information:
- Location: Bern, Switzerland
- Type of employment: temporary, limited contract until 31.12.2023.
- Start date: ASAP
- Workload: 32.8 hours per week
Position Purpose:
Assist the Regulatory Compliance team with the following tasks, but not exclusively:
- Authority
- and customer inspections at the Bern site
- Preparation of GMP documents for regulatory submissions
- Responses to questions from regulators
- Coordination, performance and follow-up of paper based GMP inspections
- Preparation of GMP-certificate renewal and tender relevant documentation based on request by Affiliates
- Change Management: Ensuring timely implementation of Regulatory Compliance related actions
- Supporting answers to Regulatory Compliance related questions from internal or external
- Perform Ad-Hoc duties in specialized field
- Participation in predetermined trainings
- Compliant performance of activities after appropriate training.
Qualifications:
- Education: University degree or university of applied sciences degree in natural sciences (e.g. Biology, Chemistry or Pharmacy).
- Experience in Quality or manufacturing in a pharmaceutical GMP environment
- Experienced in reading regulations
- Demonstrated German and English skills (written and spoken)
- Demonstrated communication skills
- Demonstrated interest for technical processes
- Experience with management of Audits is required
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