Freelance - Senior Quality and Regulatory Consultant

Solothurn  ‐ Vor Ort
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Freelance Senior Quality & Regulatory Consultant - Switzerland/ Solothurn

My client is an international Top 10 medical devices company with approximately 12.000 employees and net earnings of US$ 908 million back in 2010. The company is known for its implants and biomaterials used in correction and regeneration of human skeleton as well as surgical fixation is currently seeking for a Senior Quality and Regulatory Consultant inSwitzerland.As a Senior Quality & Regulatory Consultant you will have a challenging, varied and very important role within the company.This is your chance to become an important part of this world wide known Company and benefit from the great payment and working conditions.

Key responsibilities of the role will include, but not be limited to:

- Perform Management Reviews per protocol per schedule (gathering data, performing trending and analysis, generating presentation slide deck with appropriate summary conclusions, organizing the appropriate management for the review, and assisting in the presentation of the slide deck)
- Engage with local Quality Management and site process SMEs to ensure adequate recording, evaluating, and reporting of quality and reliability data associated with the - Quality Management System for Quality System Management Review.
- Ensure proper data transformation into thorough information and metrics.
- Alert management of product quality & compliance issues for proper and timely escalation to CAPA.
- Provide support for documentation of review completion including action plans.

You should have an expert knowledge of theUSquality systems regulations and ISO 13485 and quality and compliance in the Medical Devices Industry (GMP). Furthermore you should have the ability to build partnerships both internally and externally as well as independently analyze date and identify trends to improve overall quality systems, effectiveness, compliance and efficiency. Fluent German and English both written and spoken are absolutely necessary.

You will work on an internationally visible project where you are not only expected to sit behind your table and deliver. You will be an important part of the team and you can develop and increase the team success which benefits your personal skills for all upcoming projects, whilst also making this a personally rewarding project to work on.

For more information about this role or jobs within related specialist areas, contact Marcus Müller at Real Pharma on .

Keywords: quality, qa, quality management, qm, quality system review, SME, ISO 13485, ISO 9001, CAPA, FDA QSR, medical devices, gmp, German, English, Switzerland

To find out more about Real please visit www.realstaffing.com
Start
07/2013
Von
Real Staffing
Eingestellt
06.07.2013
Projekt-ID:
563048
Vertragsart
Freiberuflich
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