QMS expert in - Bertrand, MO, United States - Sapphire Technologies

Sapphire Technologies
Sapphire Technologies
Verified Company
Bertrand, MO, United States

1 week ago

James Miller

Posted by:

James Miller

beBee Recruiter
Freelance
Description
To ensure a prompt processing of your application, please apply exclusively via the "Apply" button. Please include a cover letter and an up-to-date resume with your application.

About the Role


Our Team:


The team is the Compliance Focal Point at the Insulin Campus Frankfurt (ICF), responsible for managing the compliance program and ensuring global/ cross-functional compliance at the ICF site.


Main Responsibilities:

  • Responsible for defining, implementing, managing, and reviewing quality management, quality system, and quality compliance programs
  • Ensures quality at the ICF campus, taking into account the current state of science and technology, and pursues continuous optimization
  • Ensures system compliance and inspection readiness
  • Provides expert knowledge to represent the company to authorities. Participates in handling authority and customer inquiries, if necessary in consultation with the supervisor
  • Implements and responsibly manages the quality assurance systems required for the group (e.g. processing of changes (change control) and deviations) in the area of responsibility
  • Coordinates the harmonization of SOPs at the ICF campus level (including SOP dashboard)
  • Represents the department in project teams as well as in other departments and external companies
  • Coordinates and ensures appropriate reporting and escalation of issues to the Quality Council System (Tier 3/2/1) and the Site Risk Profile Report (SRPR)
  • Ensures that all GMPrelevant processes within the ICF are carried out in accordance with written instructions and process descriptions
  • Monitors
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