Specialist for Validation and Qualification
at
Miltenyi Biotec
berlin, Berlin, Germany
-
Full Time
Start Date
Immediate
Expiry Date
30 Dec, 26
Salary
54000.0
Posted On
01 Oct, 26
Experience
2 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Industry
Pharmaceutical Manufacturing
Description
Contributing to and continuously ensuring high quality standards within pharmaceutical production and quality assurance
Planning, execution and documentation of cleaning validations on production facilities and media systems
Management and further development of quality-relevant validation concepts, taking into account current GMP requirements.
Preparation of sound risk analyses and participation in the determination of PDE values to safeguard production processes.
Active handling of deviations as well as definition and tracking of CAPA measures
Important technical interface function and close cooperation with production, laboratory and engineering
Creation and maintenance of quality documents, including conducting training courses for the specialist departments.
Professional support and guidance during internal and external customer and regulatory audits.
Responsibilities
Successfully completed studies in a natural science (e.g., pharmacy, pharmaceutical technology, chemistry, biotechnology) or comparable technical training with additional qualifications.
Relevant professional experience in quality assurance in a GMP-regulated environment
Solid expertise in cleaning validation and routine in creating risk analyses
A pragmatic approach to common GMP standards (EU, FDA) and confident conduct during audits.
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