Analytical Lab Equipment Qualification expert
Contracting – Brabant Wallon
Your responsibilities:
- Lead various ongoing projects related to the implementation of new analytical equipment (computerized and non-computerized) in-line data integrity requirements and Good Science Practices (GSP), Good Manufacturing practices (GMP).
- Prepare documentation (protocols, reports, URS, user guide/SOPs and other qualification -related documents)
- Support system owner (SO) / Process Data Owner (PDO) in the following task:
- Identifying critical data and critical steps throughout the business processes
- Defines appropriate processing of data in accordance with data integrity principles
- Ensures that equipment (CS and non-CS) is fit for purpose
- Determines access criteria and related restrictions
- Support the definition of data flows and archiving strategy
- Be the Single Point of Contact (SPOC) for analytical-related equipment for Engineering team, engineering of fice and equipment CQV team
- Follow the GMP/GSP procedures in place as well as the Biosafety/HSE rules in the laboratory
- Work in close collaboration with users, IT, qualif/valid, engineers and GMP/GSP QA experts
- Work according to the agreed timelines
Your profile:
- Master's Degree
- Demonstrate a high level of autonomy, flexibility and a proactive mindset.
- Ability to communicate effectively with good French and English skills
- Technical knowledge analytical techniques required to study viral vector Gene Therapy Products is an asset (UPLC, Mass spectrometry, light scattering, electrophoresis, qPCR, spectrophotometry , …
- Experience in GMP/GSP analytical equipment qualification and release (URS and SOPs writing, validation documentation review, …)
- Ability to multi-task and to openly exchange results, observations, and possible improvements
- Demonstrate ability to analyze data, with good attention to detail, and excellent record keeping and documentation
Our offer:
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
