Lims Specialist
Il y a 6 mois
Are you passionate about quality control, have Lims expertise and are looking for a challenging opportunity in the chemical sector? We have the perfect role for you
We are actively seeking a **Lims Specialist **to join our dynamic team and contribute to our commitment to excellence in the manufacture of high quality chemical products.
**Your Mission**:
As a LIMS Specialist (Superuser) within the QC Systems team, you will be responsible for the implementation and management of the LIMS system, ensuring compliance with cGMP rules, security, and procedures. You will work closely with the LIMS Key User Specialist to ensure that the LIMS, as a global PolyPeptide software, is a state-of-the-art system that supports the PolyPeptide teams.
**Your Key Responsibilities**:
- Create, modify, and approve static data in the LIMS (including sampling plans, item codes, etc.).
- Create and modify specifications in the LIMS.
- Create, edit, and approve analyses in the LIMS (validation).
- Manage the documentation aspect associated with LIMS implementations (particularly change requests) and participate in the management of deviations and CAPAs related to the use of LIMS.
- Participate in and test the implementation of features and reports.
- Report deviations related to the LIMS, technical problems, and execute corrective actions.
- Propose measures to the manager that could improve departmental work in terms of quality, efficiency, safety, etc.
- Participate in identifying potential LIMS shortcomings regarding "Data Integrity" and propose solutions.
- Train new department members and manage access requests.
- Provide necessary support to all PPL Braine LIMS users, ensure follow-up training and access management, and coach other site users.
- Backup for user access handling for QC software and participate in the periodic review of the QC computerized system.
- Participate to a quality mindset within the QC department.
**Your Profile**:
- **Experience**: Minimum of 5 years of proven experience in GMP within the pharmaceutical industry with analytical knowledge.
- **Education**: Master’s degree in Science, Bioengineering, or equivalent.
- **Skills**:
- Knowledge of LIMS (Labware is a plus).
- Strong analytical knowledge.
- Good understanding of flows (samples, data, results, certificates, etc.) in a QC environment.
- Logical and synthetic mind with the ability to see the big picture.
- Rigorous adherence to GMP rules and analytical procedures.
- Management of GMP documentation and monitoring of data integrity.
- Flexibility and critical thinking.
- Excellent team spirit and organizational skills.
- Autonomous and proactive.
- Proficiency in English (written and spoken).
- Solution-oriented with the ability to recognize, analyze, and solve problems proactively.
**What we offer**:
- a full time contract
- an attractive salary
- extra-legal benefits and insurances
- a company car
- a challenging position in an innovative and dynamic work environment with an open culture.
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