QA Manager Validation & Qualification | QA Manager Validation & Qualification (m/w/d)
Roche Diagnostics GmbH
Job Summary
This critical role as a QA Manager for Validation & Qualification, based in Mannheim, focuses on ensuring compliance and quality oversight within Sterile Drug Product Manufacturing (SDPM). The successful candidate will be responsible for reviewing and approving qualification and validation documentation for both new and existing production facilities, equipment, and the implementation of cutting-edge digital technologies, including automation and robotics solutions. Daily tasks involve managing Change Controls, classifying and processing deviations (CAPAs), conducting GMP-relevant audits and reviews, and developing qualification strategies. The role requires a Master's degree in Engineering (Pharmaceutics/Process Technology) or Natural Sciences (Pharmacy/Chemistry) coupled with at least three years of professional experience in pharmaceutical validation and qualification. Success hinges on a strong Lean-Mindset, excellent collaborative skills, and fluency in both German and English to communicate effectively across local and global teams, contributing directly to bringing groundbreaking medicines to patients quickly.
Required Skills
Education
Master's degree in Engineering (Pharmaceutical Technology or Process Engineering preferred) or Natural Sciences (Pharmacy or Chemistry)
Experience
- At least 3 years in the pharmaceutical industry
- Professional experience in Qualification and Validation
- Experience in pharmaceutical manufacturing, quality assurance, or quality control
Languages
Additional
- Not specified
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