QM representative - Martorell, PR, United States - Terra

Terra
Terra
Verified Company
Martorell, PR, United States

2 weeks ago

James Miller

Posted by:

James Miller

beBee Recruiter
Freelance
Description
Support of GMP-compliant operations (e.g. with SOPs, qualifications, validations) in the operational area of Martorell, PR

  • Monitoring of system compliance in the standard operation of the operational area
  • Support in case of deviations, change controls or other qualityinfluencing events in the operational area
  • Planning of QM measures in collaboration with affected departments
  • Creation and review of SOPs in close cooperation with relevant stakeholders
  • Planning of concepts for selfinspection, as well as conducting and participating in selfinspections; monitoring of followup measures
  • Conducting trainings in the respective department
  • Review and approval of Qdocuments (e.g. validation reports, eBRs) and monitoring of documentation
  • Participation in audits, companywide projects and maintenance of the QMS in the company

Professional and personal requirements:


  • Completed Bachelor's degree in natural sciences or completed natural science education with several years of industry experience in GMPcompliant manufacturing
  • At least five years of professional experience in the GxPregulated environment, preferably in the area of clinical supply; at least 3 years in quality assurance/control
  • Knowledge in the area of analytical method development and quality control is a plus
  • Excellent knowledge of national and international GMP regulations and laws in the pharmaceutical sector
  • Persistence, assertiveness and strong communication skills
  • Ability to work in a team in a multinational/multicultural environment
  • Very good German
More jobs from Terra
See all jobs of Terra