Equipment Operator / Process Employee

Switzerland, Project Duration: 14 Months
Location:
City: Stein
Country: Switzerland
Planned shift model: 7/3, 5/2, 5/3 and 6 / 3 7/3, 5/2, 5/3 and 6 / 3


1) Job Title: Equipment Operator
Main tasks:
• Implementation of processes / procedures in filling or post-processing in compliance with the applicable SOPs as well as GMP and GSU regulations
• Operation of the intended production facilities
• Planning, organizing and performing the activities in the specified production plan
• GDP-compliant documentation and automatic control of the manufacturing documents after the end of the order
• Execution of cleaning in accordance with the valid SOPs
• Work in filling: Zone A - Interventions in the isolator in compliance with aseptic handling regulations

2) Job title: Process employee approach
Main tasks:
• Preparation and preparation of sterile drugs including related activities such as • Preparation of the equipment required for this purpose
• Cleaning
• Documentation of the activities carried out.

3) Job title: Process employee packaging
Main tasks:
• Responsible for the monitoring of the system in his area
• Responsible for the consistent compliance with the SOPs, data integrity, hygiene and safety regulations
• Ensures cleanliness, hygiene and order in the responsible area
• Implementation of the 5S standards
• Training-appropriate assistance in cleaning systems
• Correct, complete and error-free entries in manufacturing documents, log books and data entry
• Knows the status of the production plan (e.g. backlog according to the production plan)
• Carrying out the start control (first check) and IPC
• Carrying out the final check (old order, break count)
• Carries out the Functional control of his area independently through
• Detection of deviations
• Can carry out documentation in the area assigned to him in the MES / paper PAS
• Can report faults in detail to technical support
• Can perform format changes independently
• Can report faults in detail to technical support
• Can perform format changes independently


Must:
• Completed professional training recognized in Switzerland;Preferred pharmaceuticalexperience
• Fluent in written and spoken German, must read and understand SOPs

Plus:
• Experience: GMP process reliability
• PC experience (e.g. MES, SAP, MS Office)
• Experience in operating systems in the pharmaceutical sector (e.g. autoclaves, Washing machines)
Previousknowledge of filters and filterintegrity tests Soft skills:
• Teamwork
• Flexible
• On time
• Accepts constructive feedback, is open to criticism.
• Technical understanding
• Cleaning must be fun, there is a lot of cleaning involved in filling and post-processing
• Proper
• Independent
• Sense of organization
• Clean demeanor
• PC knowledge (affinity for new technologies)