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QMS Specialist at Sartorius - ApplyBlast

QMS Specialist

Sartorius

4 months ago

3.7 on Glassdoor

Onsite

Full Time

Senior

1 applicant

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About this role

This role manages site Quality Management System strategies and procedures to ensure compliance with ISO 9001, ISO 13485, and pharmaceutical GMP standards. The manager develops local SOPs, harmonizes global procedures, and prepares the site for certification and external customer audits within the bio-process industry.

Responsibilities

Create and maintain local QMS SOPs compliant with ISO standards
Analyze gaps between global and local procedures for harmonization
Prepare site for ISO certification and external customer audits
Manage supplier quality relations and internal audit processes
Lead inter-functional quality teams across international regions

Skills

Qualifications

Bachelor's degree in Science or Quality Related fieldValidation of 3-5 years QA experience in Healthcare

About Sartorius

sartorius.com

Headquarters

Göttingen, Lower Saxony, Germany

Company Size

10001+ employees

Founded

1870

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Sartorius offers solutions for the biopharmaceutical industry and laboratories, from drug discovery and development to production platforms for biomanufacturing.