Elims Site Key User

il y a 3 semaines

Geel, Belgique Johnson & Johnson Temps plein

**Quality Control (QC)**
**eLIMS Site Key User & iLab Specialist**

Within Johnson & Johnson Innovative Medicine Supply Chain, we are actively looking for a skilled and enthusiastic QC eLIMS Site Key User & iLab Specialist (M/F/X) to join our dynamic Quality team, overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product (DP) Intermediates in Geel, Belgium.

J&J Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of SM-API and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. The Supply Chain Quality (SCQ) team supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight, In-Process-Control (IPC), release testing and release of SM-API and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.

As a QC eLIMS/iLab Specialist, your role encompasses two primary responsibilities. Fifty percent of your time will be dedicated to managing the eLIMS system as a key user. The remaining fifty percent will involve your role as an iLab Specialist, focusing on advancing the Lab Method Execution (LME) module for the transition to a paperless lab environment.

Reporting to the Lab Support QC Manager, the QC eLIMS Site Key User & iLab Specialist is responsible for:

- Serve as the Primary Point of Contact for eLIMS system management to ensure operational efficiency.
- Represent QC Geel in global site key user meetings, aligning local procedures and practices with global procedures.
- Collaborate with teams to gather requirements and initiate eLIMS intakes for process optimization.
- Facilitate interfaces between eLIMS and other systems (Lab instruments, MES, SAP, COMET).
- Conduct User Acceptance Testing (UAT) for new eLIMS features (e.g., macro’s, calculations).
- Collaborate closely with iLab SME and project lead to ensure project progress and risk mitigation.
- Develop and maintain the LME module to ensure compliance with company standards.
- Collaborate on iLab method/technique templates deployment and maintain accurate records.
- Provide end-user training and support for eLIMS and iLab systems, including troubleshooting technical issues.
- Adhere to operating procedures, safety regulations, and write work instructions and procedures for eLIMS/iLab activities.
- Provide technical input and support project discussions in meetings and workshops.
- Ensure inspection readiness and act as a spokesperson during audits and inspections.
- Stay updated on emerging technologies in laboratory informatics.

**Qualifications**:
**Job Qualifications**:

- Minimum Bachelor's degree in a relevant scientific field or equivalent experience required.
- Minimum of 5 years of relevant industry experience, including at least 3 years in analytical roles.
- Knowledge of pharmaceutical product release and stability testing is essential.
- Thorough understanding of cGMP and ICH guidelines.
- Proficiency with eLIMS system preferred, along with a solid grasp of laboratory informatics.
- Strong problem-solving abilities and meticulous attention to detail.
- Capable of working independently in a dynamic setting, managing multiple tasks effectively, and collaborating with others.
- Excellent interpersonal skills and ability to work well within a team.
- Demonstrated proficiency in managing tasks independently, adapting to dynamic environments, and collaborating effectively with stakeholders.
- Fluency in both Dutch and English languages.

**Our offer**
We offer an exciting position in an international and dynamic environment with continuous learning and growth opportunities. An attractive remuneration package, including hospital insurance and health care incentives, is provided. An inclusive team environment where diversity, and different opinions are respected and valued, and the importance of a good work-life balance is recognized.

**Diversity, Equity and Inclusion**

Johnson & Johnson is an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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