Quality Project Lead

Vor 2 Tagen


Basel, Schweiz Datalynx AG Vollzeit

For one of our clients in Basel, we are currently looking for a Quality Project Lead (M/F/d).

**Background**

Execution of defined actions from the Sandoz Separation planning under the responsibility of TRD QA Medical Devices. Backfill of capacity for general activities to allow the personnel to dedicate expertise and management engagement for all demands from the Sandoz separation project.

**General Information**
**- Start date: ASAP
- Duration: 8 months
- Extension: Possible
- Workload: 100%
- Location: Basel

**Tasks & Responsibilities**
**- Execution of the separation activities under responsibility of TRD QA Medical Devices
- Changes in the medical device certifications
- Establishment of processes and contracts for the new EU Authorised Representative on the Pharmaceutical Manufacturing site in Austria
- Preparation for the verification audits by Notified Body for the submitted changes
- Engagement with Notified Body for the issuance of the post separation certificates
- Participation in the relevant medical device workstreams
- Revisions of Quality agreements involving medical devices,
- Expert support for medical devices in interdependent WorkStreams and functional meetings

**Must Haves**:

- 5+ year Solid experience in medical devices, with am emphasis on Quality Assurance and Regulatory
- Preference for medical device experience in drug delivery systems, in the Pharma industry
- 3-5 years Experience in project management
- Experience with exchange with Notified Body, and management of the associated certificates
- English is an absolute need, German desired

**Contact**:
Jan Schmitz-Elsen
Talent Acquisition Consultant
+41 79 425 10 45



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