For a client in the region of Puurs/Bornem we are looking for an Equipment Qualification Engineer QC Chemistry.
Do you have at least 1 year of experience:
- In the Pharmaceutical industry and;
- In GMP (validation/change control,…) and;
- In Quality Control
Then you might be the candidate we are looking for!
As an Equipment Qualification Engineer QC Chemistry, you are responsible for the selection and purchase of new equipment based on URS information. You also determine the qualification approach, follow up on system qualification activities (IQ, OQ, PQ) and you are responsible for the delivery of all the accompanying documentation according to the regulatory- and compliance requirements.
- Selection and purchase of new equipment based on URS information;
- Determination of qualification approach, follow up on system qualification activities (IQ, OQ, PQ) and the delivery of all the accompanying documentation according to the regulatory- and compliance requirements;
- Responsible for the processes and procedures regarding equipment qualification and equipment specific procedures. Explanation of these processes and procedures during audits, if required;
- Offering technical support to lab centers in case of questions, problems, defects, etc.;
- Active participation in the QMS system team Lab Equipment Qualification.
- Master degree (industry) pharmacist or;
- Bio-engineer chemistry/cell- and gene biotechnology or;
- Industrial engineer chemistry/biochemistry or;
- Master degree analytical chemistry
- Broad knowledge of Equipment qualification- and validation (V-cycle);
- Theoretical- and practical knowledge of devices in a QC environment;
- Knowledge of computer system validation is a big plus.
- Constructive and pro-active attitude;
- Strives for harmonization and standardization of processes;
- Team player who takes responsibility for own projects and submits them on time independently.
Anneleen De Vos
015 21 11 04