Location: Switzerland - Glattbrugg/Zurich
Function: Quality Management
Company: Vifor Pharma
We are currently looking for a Clinical Quality Assurance Manager/Auditor to join our Quality Management team in Switzerland. You can either work from our offices in Switzerland or possibly from other Vifor office locations in Europe, consideration will also be given to home office based European candidates.
Your responsibilities will include:
- Independently conduct external & internal audits for QM CMRS (incl. for-cause audits)
- Monitor audit responses and corrective action to ensure accuracy and completeness
- Act as CQA Auditing representative in designated clinical study teams and provide internal guidance and consulting for trial GCP and related regulatory issues
- Act as CQA Auditing representative for study documents compliance verification (e.g. product specific/trial specific ICF, protocol, CSR, IB, CRF etc.)
- Involvement in QM CMRS audit CAPA management (tracking, oversight, follow-up, closure)
- CQA Audit documentation management and maintenance (including audit database and trial and global audit plans)
- Lead and/or contribute to Quality Risk Management (QRM) activities in Clinical trials
- Keep QM apprised of compliance and personnel issues through periodic reports
- Generate and provide metrics, status and other information in relation with GCPand GVP, as required by management
- Perform other duties as assigned, e.g. GCP training, support of Head QM CMRS, Head CQA
- Auditing and Head PV QA in Regulatory Authority inspection preparation, conduct and post-inspection activities
We would like to welcome the following experience and skills for the role:
- University degree or equivalent in health sciences, nursing, pharmacy or related field
- Minimum of 2 years’ experience in GCP auditing with FDA/EMA/Global regulatory requirements and ICH guidelines (monitoring or clinical operations experience are acceptable)
- Experience in regulated environment, preferably pharmaceutical or CRO industry
- This role involves minimum 20%-40% travel
- Preferred Requirements: Ability to work independently and collaboratively in a challenging regulatory environment as part of an experienced team of auditors
You describe yourself as a dynamic and flexible person with good communications skills. With the ability to work independently and collaboratively in a challenging regulatory environment as part of an experienced team of auditors.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.