operations support specialist in zug

posted
job type
temporary
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job details

posted
location
zug
job category
Bau
job type
temporary
reference number
206664-11
phone
058 201 45 00

job description

Our client, an international pharmaceutical company in Schaffhausen, is currently looking for an Operations Support Specialist 100% - 1 year Temporary contract


Your responsibilities will include:

  • Organization and support of two manufacturing and two packaging lines of STERRAD Cassettes (medical devices) in compliance with all relevant GMP and safety requirements.

  • Investigation lead of production non-conformances and CAPA's.

  • Responsible for on-time preparation and update of all manufacturing documents (recipes in SAP systems and SOP's/ WI's in EZDoc system).

  • Coordination and lead of change controls.

  • 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).

  • Supports production audit readiness and the back office during 3rd party inspections and audits (e.g. FDA, Notified Body, or Customer Audit).

  • Preparation and execution of training for production staff.

  • Investigation and documentation of complaints.

qualification

Required skills:


  • Minimum Bachelor's degree, advanced degree preferred.

  • 2+ years of previous experience in medical device, pharmaceutical or other highly regulated industry (of manufacturing, packaging or quality area).

  • Very experienced in leading and complete NC's/ CAPA's/ Change Controls in close collaboration with other departments.

  • Very good communication skills in German and English are required (oral and written).

  • Experienced in SAP applications.

  • Accountability and excellence in execution.

  • Excellent coordination skills, high learning agility and open mindset for change.

  • Willingness of on-call (standby) duty is required.

  • LEAN and KAIZEN skills required, Six Sigma Process Excellence Green or Black Belt Certification preferred.