Quality Assurance Associate
Vor 2 Tagen
Beschreibung:
We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience.
Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest standards for quality, ethics and discretion.
For our client, a renowned pharmaceutical company based in Bern, we are looking for a** Quality Assurance Associate**
**Quality Assurance Associate**:
**Background**
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1800 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.
**Task and Responsibilites**
- Support Seqirus and CSL Vifor integration tasks including data management in relevant Quality management systems (eg DMS), document review/update and data migration, as appropriate.
- Collect, compile and QC monthly compliance data and enter in relevant systems in a timely manner.
- Ensure correct entry and formatting conventions
- Analyze compliance data and draft compliance report using data collected.
- Ensure correct formatting of graphs and charts.
- Ensure timely release and communication of the compliance reports.
- Manage feedback from reviewers and contributors.
- Escalate to manager as required.
- Update data requirements (eg. PV Agreements rule) in relevant systems.
- Support in gathering information and developing requirements to monitor for the local PV System Oversight and vendor oversight.
- Support the PV Excellence and Compliance managers in operational equirements/tasks, as required.
- Any other tasks that will be assigned related to projects, integration or operational activities
**You must have these qualifications / Expierences**
Required education:
University degree, ideally relating to life or natural sciences or quality/quality management.
**Experience**:
3-5 years experience in Quality management/quality assurance or pharmacovigilance compliance and quality systems
**Language**:
proficient in English
Additional Competencies:
Experience in Quality systems (Deviation & CAPA Management, change control, and SOP and training systems)
Understanding of pharmacovigilance regulations (especially GVP Module 1)
Excellent written and verbal communication skills
This request is marked "Swiss Remote" but will be based in Zürich
**Work hours**
- 41. h./ Week
**Are you interested?
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