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Global Regulatory Affairs - Process Excellence & Compliance Scientist

Swisslinx
Bern, Schweiz
Gepostet vor etwa 1 Monat Befristet Competitive
Global Regulatory Affairs - Process Excellence & Compliance Scientist
On behalf of our client, an international Biotechnology company based in Bern, Swisslinx is looking for a GRA Process Excellence & Compliance Scientist. This is a 6-months contract position with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.

- Start date: ASAP
- Duration: 6 months
- Work location: Bern (possible to work remotely part-time)
- Workload: 100%

Your mission:

Procedural documents/Quality Management System:
- Responsible for the GRA QMS, including implementation of QMS strategy and tactics
- Responsible for supporting and coordinating GRA internal Policy/SOP/WI creation, review, approval, version control and ensuring consistency across
- Regular review of global procedural documents status and analysis of status reports
- Ensure continuous compliance with QMS procedural documents
- Represent GRA in global projects associated with QMS
- Supporting the development of KPIs for key compliance activities and analyze quality compliance metrics
- Represent GRA in global projects, audits and inspections associated with the GRA QMS

Training:
- Ensure adherence to GRA training strategy
- Implement and maintain training curricula for all GRA functions
- Maintain a GRA training database
- Oversee training status across GRA, collect and analyze regular reports and provide consolidated status report
- Tracking of continuous compliance with training requirements
- Develop and maintain training related procedural documents and tools
- Represent GRA in global projects, audits and inspections associated with global training management systems
- Support the implementation of the GRA training governance at all sites globally

Audits/Inspections:
- Act as a key contact for internal audits of GRA, including coordination of CAPA responses
- Support regulatory agency inspections including pre-inspection and related follow-up activities
- Coordinate and conduct audits of GRA global processes in order to assess and/or ensure compliance with relevant guidelines, legal requirements and GxP guidelines
- Ensure compliance of GRA local procedures with GRA global procedural documents
- Contribute to audit and inspection readiness activities
- Track audits & inspections performed in GRA
- Oversee and track quality incompliances in GRA
- Track status of CAPAs assigned to GRA resulting from Audits, Inspections and GRA internal sources

Your profile:

- A degree (min. BSc or equivalent in life science, pharmacy, law or business economics preferred)
- Experience in managing Quality Management Systems including procedural document development
- Training requirements and conducting audits
- Demonstrated sound judgment and flexible approach to managing situations
- Customer service focus
- Experienced in working within a Matrix Environment
- Comfortable working across the business and 2-3 levels above his/her grade
- Knowledge of ICH guidelines/GCP, related regulatory guidelines and experience in scientific/medical research
- Demonstrated project management skills. Possesses excellent planning, time management & coordination skills
- Demonstrated ability to problem solving and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies
- Good interpersonal skills
- Fluent in English
- Microsoft Office Skills, focus in Excel skills

For further information or to apply please do not hesitate to contact Alina Peeva, recruiter: alina.peeva@swisslinx.com
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA

I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)
Job ID  14396
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