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.
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.