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Q.C. Compliance Specialist – LIMS Expert
Grünenthal Group. Work within the Quality Department as a Business Process Expert of LIMS .
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- International team with a powerful spirit of collaboration
- Equal employment opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
LIMS implementationLIMS customizationLIMS configurationPQ validation testsmaster data managementprocess mappingfit-gap analysisvalidation techniquesrisk managementdata integrity
Soft Skills
excellent communicationproblem solvingagilitycollaborationtrainingworkshop facilitationcross-functional teamworkadaptabilityfast-paced workinterpersonal skills