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Q.c. compliance specialist - lims expert (origgio)

Origgio
Grünenthal Group
Pubblicato il 12 giugno
Descrizione

Our people in

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Manufacturing & Global Operations

share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.
What The Job Looks Like

You will work within the Quality Department as a Business Process Expert of LIMS
LIMS continuous implementation
Design specification, customization and configuration of LIMS in order to satisfy the business requirement
PQ validation tests of LIMS system
Setting of master data in LIMS
Support on LIMS relevant topics after go‑live for all business departments
Support on LIMS relevant topics for all business departments
Workshops and daily meetings with cross functional and international teams
Training on Qualified Persons and QC analysts
Daily collaboration with Business Process Owners, Business Process Managers, IT consultants, and Project Managers to carry on the project
Support digital roadmap implementation on Quality Control project
Process mapping of Quality Control processes
Fit‑gap analysis between processes in the headquarter and the local sites
Writing and reviewing of project documentation: flowcharts, Blueprint, SOPs, User Requirements, Risk Assessments, Validation documents
What You’ll Bring To The Table

Experience in a similar role, such as BPE or LIMS Key User within pharma companies
Familiarity with SAP QM Module is xlwpduy highly beneficial
Fluency in Italian and English
Previous experience in a pharmaceutical manufacturing site in Quality Control Department is beneficial
Excellent communication skills, Problem solver, agility, willing to work in a fast‑paced environment
Knowledge of validation techniques (GMP; GAMP; WHO, CFR21…), risk management, data management, data integrity knowledges
Grünenthal offers equal employment opportunities. Recruitment will take place without distinction with regard to religion, gender, sexual orientation, age, origin, disability or other relevant categories

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