Senior Operations Support Specialist

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. Switzerland
Schaffhausen
Posting date: 01 Jul 2019
24096_1561980573

ProClinical is advertising a vacancy for a Senior Operations Support Specialist with a global technology company entering the medical device space. The position, which is based in Switzerland, offers an exciting opportunity to join an innovative and entrepreneurial organisation to provide expertise and bolster a career in the medical device sector.

Job Responsibilities:

  • Organization and support of two manufacturing and two packaging lines of STERRAD Cassettes (medical devices) in compliance with all relevant GMP and safety requirements.
  • SAP key user/ production master data management (MDM).
  • Responsible for on-time preparation and update of all manufacturing documents (recipes in SAP systems and SOP's/ WI's in EZDoc system).
  • Track, analyze and prepare production reports and metrics.
  • Define, coordinate and manage production projects and improvements (single point of contact) in close collaboration with other departments (AVOR, Planning, Engineering & Maintenance, Quality and Logistic).
  • Coordination and lead of change controls.
  • Responsible for production audit readiness and support the back office during 3rd party inspections and audits (e.g. FDA, Notified Body, or Customer Audit).
  • Investigation lead of production non-conformances and CAPA's.
  • Preparation and execution of trainings for production staff.
  • Coordination and management of validations/ qualifications and owner of the test run process.
  • Investigation and documentation of complaints.
  • Other duties may need to be performed as assigned.

Skills and Requirements:

  • Minimum Bachelor's degree, advanced degree preferred.
  • 5+ years of previous experience in medical device, pharmaceutical or other highly regulated industry (of manufacturing, packaging or quality area).
  • Advanced communication skills in German and English (oral and written).
  • Very experienced in SAP applications (SAP key user).
  • Accountability and excellence in execution
  • LEAN and KAIZEN skills required, Six Sigma Process Excellence Green or Black Belt Certification preferred.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Josh Volpe at +44 203 800 1292 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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