Roche
Pharmaceuticals
QualificationEngineer/Qualifizierungsingenieur(m/w/d)
“Qualification Engineer/Qualifizierungsingenieur (m/w/d) at Roche. Skills: Qualification documents, GMP compliance, Regulatory guidelines. Create qualification and requalification documents. Represent work in inspections and audits”
What You'll Achieve.
Ensure pharmaceutical plants run smoothly; Ensure all legal and GMP requirements are met; Increase efficiency through continuous, data-based qualification
Industry & Context.
Conflict resolution
Represent work in internal and external inspections and audits towards authorities like EMA and FDA
What They're Looking For.
Must Have
Technical degree (Bachelor, Master) in Pharmaceutical Engineering, Biotechnology, Process Engineering or relevant vocational training with several years of professional experience, Extensive experience in the pharmaceutical industry, especially in sterile production and qualification, Sound knowledge of pharmaceutical manufacturing processes and technologies as well as GMP, EU and FDA guidelines and relevant pharmacopoeias, Fluent German and English language skills (written and spoken), High level of teamwork and responsibility, Ability for interdisciplinary thinking, conflict resolution, integration and persuasion
What You'll Do.
Create qualification and requalification documents
Represent work in inspections and audits
Support development of qualification concepts
Manage external service providers
Exchange with other sites
How You'll Work.
Team & Collaboration
Work with colleagues in the MSAT team; Collaborate with internal interface departments; Exchange with other sites
Communication Scope
Fluent German and English language skills (written and spoken); Expressive ability
Applying for this Qualification Engineer/Qualifizierungsingenieur (m/w/d) role?
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