Engineer QC Validation
Position: Engineer QC - Validation
Reports to the Supervisor Validation
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 at Prothya Biosolutions BE. In doing so, you contribute to ensuring that the quality of the pharmaceutical products of Prothya Biosolutions BE meet the European and American cGMP 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 in the development and implementation of method validation protocols;
- You participate in the optimization and implementation of methods;
- You coordinate and document QC in/out transfer methods;
- You participate in projects that impact the validation of the lab’s methods;
- You ensure the correct reporting and follow-up of actions related to the validation 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 stress resistant.
Prothya Biosolutions produces plasma preparations (including known products such as Cofact, Nanogam and Albuman). In addition, Prothya collects, tests and supplies blood plasma to purification and production sites worldwide. Prothya Biosolutions' mission is to provide healthcare organizations worldwide with high-quality plasma products. The company does this by creating value for partners and contributing to the health of people who depend on essential plasma proteins. Hence, Prothya's slogan: Creating Value, Sustaining Life. The company has various office and production locations in the Netherlands and Belgium and employs around 1,000 people.
Prothya Biosolutions BE is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.
In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions BE offers once a year.
We also offer an attractive holiday system exceeding the legal holidays.
Furthermore, we value mutual respect and diversity is our strength.
For each Prothya Biosolutions BE employee, from operators to the CEO, engagement means showing initiative. We expect all colleagues to contribute to achieving our annual objectives in order to take the organization towards it future challenges and successes.
Are you interested? Send your CV and covering letter.