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Commissioning & Quality Engineer

Job description

As a Quality Engineer you ensure quality by monitoring and assuring that all operations on all levels are done according to the applicable GMP quality systems. In doing so, you contribute to ensuring the quality of pharmaceutical products and meet the European and American GMP guidelines.
As a Quality Engineer focused on validation, your emphasis is on the qualification of equipment within the Quality Control (QC) department.

Main Responsibilities and result areas:

1. You are responsible for the preparation, execution and daily management of the qualification and calibration activities within the QC department:
You are responsible for the preparation and the management of the qualification of (new) equipment (writing protocols and reports) and (monitoring) the implementation of the qualifications;
You draw up a (re)qualification and calibration strategy, including an annual plan, and ensure that it is implemented correctly;
You are responsible for the timely maintenance and the implementation of changes in the qualification of ad hoc TrackWise equipment;
You are responsible for the maintenance and repair of the equipment in consultation with the laboratory and/or suppliers;
You are responsible for following up on the implementation of qualification SOPs and updating them;
You coordinate and document the retirement of equipment that is no longer in use.

2. You cooperate with the Quality Assurance department regarding qualifications and change control;
You regularly inform about the evolution of the qualifications;
You report non-conformities in time and work actively to resolve them as soon as possible.

3. You participate in various projects that have an impact on the qualification of the lab equipment:
You participate in the optimization of the qualification activities;
You participate, when necessary, in interdepartmental meetings;
You ensure the correct reporting and follow-up of actions on equipment qualification.

4. You position yourself as an expert in the purchase of new equipment:
You draft, in conjunction with the lab, Requirement Specifications;
You play a key role regarding new equipment and its specifications;
You oversee the purchase and qualification of new equipment;
You evaluate the conformity of current methods and act accordingly as necessary.

5. You provide assistance in the validation of analytical/microbiological methods of the QC department:
You participate inProfile

Profile:

You have a Master’s degree in Chemistry, Industrial Pharmacy, Biotechnology,..
You have gained experience in equipment qualification/method validation
You are familiar with the European and American GMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures);
You are familiar with MS Office software; knowledge of SAP/TRACKWISE is a bonus;
You speak and write fluently in French, Dutch and English
You are analytical and problem solving
You are result-oriented and decisive
You are client-oriented, persuasive and cooperative
You are able to set priorities and have good organizational skills
You are stress resistant

OUR OFFER

As an AKKA consultant, you will be:

  • In charge of diverse transversal and empowering projects
  • Supported in your career by your AKKA Manager
  • Actor of your training plan and your personal and professional development
  • Member of a dynamic and collaborative community of engineers
  • Benefiting from a permanent contract
  • Benefiting from a competitive salary packages including several extra-legal benefits.
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    Commissioning & Quality Engineer

    Company:
    The AKKAdemy
    City:
    Belgium
    Contract type: 
    Permanent
    Categories: 
    Quality Engineer
    Degree level: 
    Master
    Published:
    15.01.2022
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