Q.C. Compliance Specialist - LIMS Expert
Country: Italy
City: Origgio (Varese)
Department: Global Operations & Production
Our people in 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
Each day you'll enjoy a variety of challenges, such as:
- 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
To make the most of this role and truly thrive, you should have:
- Experience in a similar role, such as BPE or LIMS Key User within pharma companies
- Familiarity with SAP QM Module is 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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Degrees of interest: Laurea in Discipline Scientifiche o Ingegneristiche