Operations — Engineering/production
Minimum level of experience required
All levels of experience
Brussels Region, Belgium
Share this opportunity
AKKA is an international engineering consulting and R&D services company. As an innovation accelerator for its clients, AKKA supports leading industry players in the automotive, aerospace, rail, space, defense, energy and life sciences sectors throughout the life cycle of their products with cutting edge digital technologies
With more than 22.000 experts in over 25 countries, AKKA is one of the leaders in its field. In Belgium, we have close to 1000 experts active in different technical fields.
As a Quality Engineer you ensure quality by monitoring and assuring that all operations on all levels are done according to the applicable cGMP quality systems.
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 in the development and implementation of method validation protocols;
You participate in the optimization and implementation of methods;
- 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 sress resistant.
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.
You may be interested in these openings
Data Engineer H/F
OPERATIONS — ENGINEERING/PRODUCTION
Ingénieur AOCS/SCAO H/F
OPERATIONS — ENGINEERING/PRODUCTION