(Senior) Validation Officer
About this opportunity
Ablynx, a Sanofi company is welcoming applications for the role of (Senior) Validation Officer for our GMP Unit.
As (Senior) Validation Officer, you will be responsible for performing qualification, validation and engineering activities in a GxP (GMP / GLP) environment.
Based on the level of experience and expertise, this position could be graded as a Senior Validation Officer or as a Validation Officer.
About Ablynx, a Sanofi Company
Ablynx, a Sanofi company, is engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Nanobodies have potential uses in the treatment of a range of serious and life-threatening human diseases. Ablynx advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology.
- You perform your activities in a GxP environment in close contact with the GMP QC Lab and GLP Lab;
- You write, review and finalize validation documentation (URS, RA, protocols, reports, trace matrix, requalification, periodic review, non-conformities) for new or existing systems (lab equipment, computerized systems) used in the GxP environment;
- You perform (re)qualification and calibration of systems used in the GxP environment;
- You interact with external and internal suppliers in function of design, validation, implementation, maintenance and calibration of systems;
- You optimize and maintain the operational procedures on validation, calibration and the life cycle of systems based on regulations and guidance documents;
- You write and maintain operating instructions for systems or software;
- You initiate and follow-up on Quality Events to ensure completion within due date;
- You organize training sessions on the operating instructions for personnel working with the system;
- You assist in technical problem solving and maintenance activities.
- Degree B. Sc. or M. Sc. in a relevant field of sciences;
- Experience with GMP guidelines and a GMP working environment;
- At least 1 year of experience in (computerized) systems validation and/or in lab equipment qualification;
- Knowledge of Data Integrity, 21 CFR Part 11 and GAMP guidelines;
- Team player, enthusiastic, independent and self-motivated;
- Excellent communication skills are required;
- Practical hands-on mentality;
- Sense for problem solving, initiative, quality, accuracy and detail;
- Excellent knowledge of English both in reading and writing.
It would be advantageous to have (not essential):
- Experience in project management of validation projects is an asset;
- Experience with any of the following equipment/techniques is a plus: LC, CE, Biacore, Karl Fischer, Casy, spectrophotometers, microplate readers;
- Fluency in Dutch, while not essential, is a plus.
What Sanofi can offer you
- This is a challenging role with a lot of variation and a good balance between documentation and hands-on activities.
Empower Life Everyday
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