You will be responsible for the aseptic validation design strategies and the validation activities of aseptic processes/clean rooms/equipment used in Aseptic Manufacturing. The aseptic validation consists of :
- Environmental Monitoring validation
- Airflow studies
- Aseptic Process Simulations (Mediafills)
1. Must become an expert in the following domains:
- Aseptic Validation of Processes/Clean Rooms & Equipment
- Knowledge and correct interpretation of all involved regulation
- Support in problem solving
2. The contractor can be owner of a Quality System3. 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
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 the 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 the 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.