You will be responsible for the aseptic validation design strategies, validation activities and implementation of a database which is used to log routine environmental monitoring samples in an Aseptic Manufacturing facility.
The main project is the validation and implementation of the database., but other improvement projects can also be part of the tasks.
A broad interest in environmental monitoring of facilities is required.
The tasks consist of :
- Validation activities of the database (part of a global team, requires frequent communication in English)
- Implement database in the organization (local implementation at the site, this includes coordination of the installation, writing or adjusting work instructions, train users etc.)
- Improve current processes (use the new features of the database system to improve current processes)
- Responsible for the validation activities:
- Preparation of the URS for test equipment
- Preparation of the validation plan and protocol
- Coordination and follow up of the practical execution of the validation tests
- Preparation of the final validation report
- Must become an expert in the following domains:
- Aseptic Validation of Processes/Clean Rooms & Equipment
- Knowledge and correct interpretation of all involved Pfizer/cGMP regulation
- Support in problem solving
- Be owner of a Quality System
- to identify and close system performance or compliance gaps according to cGMP regulation
- to improve the efficiency of the systems
- to make sure that the correct SOPs/WI are in place
- to share the system knowledge with team members/involved colleagues from production, engineering, QA