Stellenbeschreibung
Randstad (Switzerland) AG is looking for an experienced Process Expert with a relevant backround in Drug Product to join the team in Visp, Switzerland.
Key responsibilities:
- Being accountable for identification and implementation of the new Annex 1 requirements related to regulations for sterile manufacturing and aseptic practices
- Ensure that requirements and processes are aligned with best industry practices and trends
- Collaborate closely with different sites producing sterile product and act as a link between different departments (Operations, QA, QC, global functions, etc.)
- Responsible for performing gap analysis and risk assessment in collaboration with local and global SMEs for aseptic operations
- Define and organize appropriate trainings on the identified implementation related to the new Annex 1 requirements
- Actively define the communication strategies with the health authorities and customers
- Bachelor’s/ master’s degree / PhD, preferred area of study: Pharmaceutical Technology, Biotechnology, Chemistry, Pharmacy or equivalent scientific degree
- At least 2 years of experience in aseptic filling in the pharmaceutical or biotechnology industry
- Preferred knowledge of sterile filtration, freeze drying, CCIT and single use systems
- Proven experience and competence in Good Manufacturing Practice (cGMP) and familiar with new Annex 1 requirements
- Fluent in English
- Highly collaborative, results oriented and with excellent interpersonal communication skills
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