EXPERT REMEDIATION - EU MANAGEMENT REVIEW LEGACY REVIEW, 8month

Switzerland  ‐ Vor Ort
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EXPERT REMEDIATION - EU MANAGEMENT REVIEW LEGACY REVIEW, 8months Switzerland

Perform remediation activities generated from the Management Review Legacy Reviews to ensure adequate product and process risk review.

MAIN DUTIES & RESPONSIBILITIES:

* Perform Management Review remediation per schedule.
* Access product and process risk and alert management of product quality & compliance issues for proper and timely escalation to CAPA.
* Engage with local Quality Management and site process SMEs to ensure adequate actions are taken.
* Provide support for documentation of remediation activities.
* TO ADHERE TO THE COMPANY'S PROCEDURES AS DETAILED IN THE SOP MANUAL

KEY COMPETENCIES REQUIRED:

* Strong collaboration and influencing skills to partner effectively with various functions and across Operating Units - Both Internally and Externally
* Expert knowledge of the US Quality System Regulations and ISO 13485
* Demonstrated track record of delivering best in class results in the Quality Systems area
* The ability to independently execute risk assessments and remediation activities
* Fluent in German and in English - able to review CAPA & sub-system data and documents & interact with Quality Management & site process SMEs

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:

* Strong knowledge of quality and compliance for Medical Device Industry (GMPs).
* Working knowledge of Quality System Regulations.
* A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement
* Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards
* Demonstrated knowledge of business impact of compliance issues and risk management
* Proven ability to build partnerships both internally and externally

Place of work for all Positions.
  • Switzerland¨
  • Office-based, 5-day/week


More Details:
  • 8 Months fulltime
  • Location: Zuchwil,Switzerland
  • 100% onsite
  • Start date: May 2013


SUBJECT MATTER EXPERT EU MANAGEMENT REVIEW LEGACY REVIEW, 8months Switzerland

We are urgently looking for Consultants (Freelance) , in one of the biggest Pharma Companies of the World.

Location: centralSwitzerland

Start date. May 2013

Perform Management Review Legacy Reviews per protocol to ensure adequate review of quality and reliability data associated with the Quality Management System.

MAIN DUTIES & RESPONSIBILITIES:

* Perform Management Reviews per protocol per schedule. This includes 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.
* Demonstrate knowledge of, and ability to, apply appropriate statistical techniques in support of trending and analysis.
* 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.
* TO ADHERE TO THE COMPANY'S PROCEDURES AS DETAILED IN THE SOP MANUAL

KEY COMPETENCIES REQUIRED:

* Strong collaboration and influencing skills to partner effectively with various functions and across Operating Units - Both Internally and Externally
* Expert knowledge of the US Quality System Regulations and ISO 13485
* Demonstrated track record of delivering best in class results in the Quality Systems area
* The ability to independently analyze data and identify trends to improve overall quality systems compliance, effectiveness, and efficiency
* Fluent in German and in English - able to review CAPA & sub-system data and documents & interact with Quality Management & site process SMEs

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:

* Strong knowledge of quality and compliance for Medical Device Industry (GMPs).
* Working knowledge of Quality System Regulations.
* A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement
* Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards
* Demonstrated knowledge of business impact of compliance issues and risk management
* Proven ability to build partnerships both internally and externally

Place of work for all Positions.
  • Switzerland¨
  • Office-based, 5-day/week


More Details:
  • 8 Months fulltime
  • Location: Zuchwil,Switzerland
  • 100% onsite
  • Start date: May 2013


Please notice: European citizens are preferred

For a confidential discussion about regulatory affairs projects in Switzerland, or to apply, then send your CV to or call me.

I am a specialist recruitment consultant in regulatory affairs for the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on Switzerland.

If you are a Pharmaceutical professional looking for your next opportunity, then please don't hesitate to get in contact with me. Alternatively if you are currently looking for skilled individuals for the development of your organisation, then I can certainly help.
Your personal contact:

Kristina Bröckel

Regulatory Affairs Consultant

Tel:

mailto:

To find out more about Real please visit www.realstaffing.com
Start
05/2013
Dauer
7 months
Von
Real Staffing
Eingestellt
20.04.2013
Projekt-ID:
524633
Vertragsart
Freiberuflich
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