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Analyst eLIMS CoE QC Operations

Vacaturenummer: A2200083
Janssen Biologics B.V. - Leiden (Nederland)

For our client, Janssen Biologics B.V., we are looking for an Analyst eLIMS CoE QC Operations.

Keywords

  • Lab processes of Large molecules;
  • eLims and automation experience;
  • cGMP, FDA, ICH Q8, 9, 10.


Profile
As Analyst eLIMS, you will work within the eLIMS CoE and you are an expert in data set-ups in the eLIMS system to support lab processes including paperless, product release and CofA generations, especially to New Product Implementation for Large Molecules and Vaccines. You independently create, maintain and review high quality data set-ups, integrate instruments and applications and translate specifications within the eLIMS system using current business processes. You will review and test system updates, create and manage any system related documents, and identify and drive process improvements.
You are expected to fully understand the sites master data requirements and lab processes to ensure all configurations are accurate and complete.
You can develop training materials to enable sharing of knowledge within the team. You will train others in immediate team while continuously improving personal training and knowledge. Finally, you are able to support projects within QC Operations, e.g. implementation of iLABs projects, harmonisation / standardisation of processes.


Who we're looking for
We are looking for candidates with at least a B.Sc. degree with 2 – 4 years of working experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) with knowledge and experience with LIMS and Quality systems. Extensive other experience with analytical testing, quality control or IT is preferred.
You have the ability to manage multiple issues, organise activities, prioritise, and escalate to management when appropriate. Broad knowledge and experience with cGMPs, applicable regulations (e.g., FDA, ICH Q8, 9, 10), and risk management.
You have strong written and verbal communication skills in English, and the ability to develop and provide training to colleagues and partners.
You are able to maintain a clear line of communication with the eLIMS CoE lead.


Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.



Additional vacancy information
Reference:A2200083
Contract:Projectmatig dienstverband met CLS Services
Education:HBO/BSc. WO/MSc.
Employment terms:Salary: 3500 - 4300
Days of leave: 25 +11
Mainly working remote
See here our other employment terms for this vacancy
Publication date:27-6-2022
Location:View location with Google Maps
Contactperson:Jan Paul Favier
+31 (0)88 22 77 555

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.