The consultant is 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 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 Puurs 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)
The main project is the validation and implementation of the database. Other improvement projects can also be part of the tasks. A broad interest in environmental monitoring of facilities is required.
1. 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
2. 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
3. The contractor can be owner of a Quality System
- to identify and close system performance or compliance gaps according to cGMP/Pfizer 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.
4. The consultant directs analysts if applicable, who are appointed to specific tasks for the assigned projects. She/he is responsible for the reliability of the obtained results and final validation reports.
5. He/she assures that test methods used comply with current legal and Pfizer standards.
6. Prepares a maintenance/calibration program that assures that the used equipment is well maintained, validated and calibrated at regular intervals according GMP requirements and Pfizer guidelines.
7. Assures proper training and development of personnel concerning the assigned projects to obtain a proper transfer to the routine testing process.
8. Improve productivity and avoid unnecessary costs in relation to the assigned projects and plans for timely implementation.
9. Serves as a coordinator between the Aseptic design/ Micro lab and other departments as Product Support, engineering, production, maintenance, the chemical lab and environmental control operations.
10. The contractor proposes for his expert domain personnel- and equipment budgets and prepares comparative studies on equipment to be purchased.
11. The contractor will participate in corporate and site teams and audits related to his/her expert domains.
12. He/she is responsible for the safety in his/her expert domain.