Leopoldsburg, Flemish Region, Belgium
Lies is a very enthusiastic, highly motivated and studious person. Who is able to work independently or as a team player, client orientated and by nature very social. She can work well under pressure and is highly determined to reach and focus on her postulated goals. Experience with dealing with clients, management knowledge that is useful in everyday situations, basic knowledge about SAP, LiMS, MES, Trackwise, cGXP, basic engineering, ISO 13485, Audits, ISO 22716.c
As a waitress it is important to make sure all the custumers are provided with a service that their drinks are always filled, they are given food when hungry and do not feel the need to have any complaints. In summary as with most jobs, keep the customers happy and make sure everything runs smoothly. Lies her job is the previous noted, but also training new staff, making sure she and her colleagues do not make any mistakes and when there are problems of any kind, they are resolved in the best way possible. She also takes care of the communication between the employees of certain events, situations or other information that needs to be provided.
− Reviewing the production records for a correct filling in of the production process information. − Owner of the QMS documentation system in the company. − Handling non-conformities, sending supplier complaints, internal quality issues, customer complaints. − Performing internal audits, standing by for external audits − Follow-up on closing outstanding non-conformities and responsible for CAPAs being completed. − Providing quality plans for the manufactured products. − Advising the production department where needed. − Back-up for the quality manager.
During the shutdown period of one of the plants at Janssen Pharmaceutica, which produces pharmaceutical active products, a renovation project was performed. − Making sure all the predetermined steps of the renovation have been performed, are in a GMP correct state and pass all the criteria. − Review of all the construction documentation, components used, P&ID changes, BOM, Green tags, blue tags, sample results, … and make sure the are all compliant and conform. − Starting COCs in trackwise, making sure the pre- and post-actions are performed and add evidence to the COC documentation. − Communicate with project engineers, construction engineers, QA, safety and production.