QM representative - Martorell, PR, United States - Terra
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
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