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Qualification Engineer (French Speaking) - Brussels, Belgium - 2 Month

Posted on Oct 14, 2020 by ABW Recruitment

Not Specified, Belgium
IT
Immediate Start
€510 - €510 Daily
Contract/Project


My Client a Leading Pharmaceutical Company based in Brussels Belgium requires a Qualification Engineer ( French Speaking)

Description:

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

Pharma 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.

Responsibilities:

  • 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

Profile:

  • 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.

 




Reference: 972414576

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