Q.C. Compliance Specialist - LIMS Expert
Department: Global Operations & Production
Job ID: 45205
What the job looks like
* You will work within the Quality Department as a Business Process Expert of LIMS
* 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 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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