Qualification Engineer (French Speaking) - Brussels, Belgium - 2 Month
Posted on Oct 14, 2020 by ABW Recruitment
My Client a Leading Pharmaceutical Company based in Brussels Belgium requires a Qualification Engineer ( French Speaking)
The mission is to be carried out within the Site Process Validation department of Braine-Alleud (Belgium), which is responsible for taking charge of the site's qualification and validation activities.
The department is made up of 3 Business Units:
DS & Pilot BU
BU IV & Bio
More specifically, the mission will take place in the DS & Pilot Business Unit.
As part of the implementation of a new process, the mission is to monitor the qualification and validation of it.
The person will be in charge of:
- Support as SME qualification.
- Define and propose the qualification strategy for the processes for which he/she is responsible, in collaboration with the team in place.
- Write and review the qualification documents for the equipment or processes for which he/she is responsible in accordance with UCB procedures.
- Writing/processing/checking of qualification documents.
- Plan, organize and carry out qualification activities that concern him, in conjunction with the project team.
- Ensure that the documentation and methods used are consistent with the requirements in force.
- Participation in FAT/SAT and the start-up of equipment (a one-off trip could be requested).
- Processing of results (management of non-conformities, changes, writing of reports).
- Report to his/her hierarchy any problem having an impact on the quality of the products manufactured or the progress of the project.
- Take the necessary decisions during drifts impacting the validation strategy in collaboration with the Q/V Manager and the project team
- Depending on the priorities of the projects and their progress, the workload may change.
- Guarantee the validated state of equipment and processes used in production
- Guarantee the permanent audit of the Q/V files of an installation or a process
- Explain the qualification activity at the level of the different units (production, quality, maintenance, engineering, etc.)
- Bring field skills for the development of the methodology, in support of the "Validation System Manager"
- Ensure compliance with current legislation and internal security rules
- Engineer or equivalent experience.
- A minimum of 4 years experience in the field of qualification and validation in a pharmaceutical industrial environment.
- Knowledge of the qualification of computerized systems is an asset.
- Experience in process validation and cleaning.
- Fluent French (activities, documents and work environment in French).
- Understanding and ease of expression in English (documents and contacts with external companies).
- Ability to take responsibilities and decisions.
- Ability to manage contacts with the various project stakeholders.
- Ability to be innovative, entrepreneurship.
- Research and analyze the causes of failure, and propose innovative solutions to Remedy them.
- Autonomous and adaptable.
- Rigorous and organized.
- Customer oriented and teamwork.
- Ability to coordinate different qualification activities simultaneously.
- Field oriented and respect of the schedule.