Senior Qualification Technician
Locations: Beerse, Belgium
Functions: Operations (Generalist)
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Requisition ID: 1905776019W
In the department of Small Molecule Pharmaceutical Development, SMPD (sub department Business Support & Compliance, BS&C) we are looking for (m/f): (Located in Beerse, Belgium)
Senior Qualification Technician (Systems)
You are member of the Business Support & Compliance team (BS&C):
Our mission is to support the output and performance of Small Molecule Pharmaceutical Development for output by being experts in Business Support & Compliance.
Contributing to Small Molecule Pharmaceutical Development output and performance:
* Delivering the portfolio according to plan
* Zero serious safety, health or environmental incidents
* Compliant and maintained instrumentation and infrastructure
* Compliant business processes and trained employees
* Continuous Improvement and meeting Financial Commitments
In this team, you are part of the sub team for Lab Instrument Qualification (LIQ)
General Lab Instrument/Systems qualification responsibilities:
* You are the Janssen representative for the execution of LIQ, with the focus on (data) systems. You are the middle man between the IT department and the external qualification engineer group.
* You will provide support to the technique responsible / analyst / system owner / system provider during the execution of lab instrument/systems qualification activities (OQ, PQ)
* You are responsible for data integrity of lab instrument/systems (security/access management/audit trail review/...)
* You are involved in the selection and justification of supplier, type and design of new lab instrument/systems in consultation with technique responsible/ system owner if required (CAPEX process)
* You will provide input for the planning and follow up of all lab instrument/systems within the SMPD Beerse labs
* You will provide input for the setup of the lab instrument validation plan (VMP) (Inventory, qualification status and additional information as required)
* You are an expert in the setup of qualification approach/documentation for the introduction of new lab instrument/systems, PAT systems and changes to operational lab instrument/systems based upon the Intended use and regulatory/compliance requirements
* You will a key player in managing the effectiveness of qualifications from purchase until release, by your role in decision taking and issue resolution.
* Execution and follow up of the lab instrument/systems qualification activities (IQ, 00, PQ)
* You are involved in the troubleshooting process for calibration or qualification related incidents, defects or other problems to assure the continued operation of the lab instrument/system
* You are a spokesperson for qualification of lab instrument/system related topics during internal and external audits if required
* You are Master in Sciences or IT or equivalent through experience
* You have experience in pharmaceutical project management is a must.
* You have experience in a GMP environment
* You have working knowledge of quality systems
* You have theoretical and practical knowledge of the instruments used in pharmaceutical labs and the current qualification and validation methodology. Knowledge of and/or experience of the application within Janssen is an asset
* You are proficient in, or have a large interest in IT solutions, related to lab instruments. This includes automated integrated systems.
* You have a good working knowledge of standard systems/platforms as MS Office, SharePoint, SAP-eStream, ELN, …
* You have good communication skills, client focus and flexibility. Your communication is mostly in Dutch, but a good knowledge of spoken and written English is a prerequisite
* Green belt in business processes excellence is recommended
* You are able to use visual management tools
* You have excellent organizational skills
Deze vacature is tot 16/12 exclusief voorbehouden voor medewerkers wiens functie wegvalt door een organisatorische wijziging. Deze kandidaten worden met voorrang in het selectieproces opgenomen. De screening van andere kandidaten zal pas na deze periode gebeuren.
Janssen Pharmaceutica N.V. (7555)