Quality & Regulatory Specialist at SofMedica ensuring compliance with quality standards and managing quality management systems. Overseeing supplier qualifications and participating in audits.
About the role
- Business Process Expert for LIMS, focusing on implementation and support within Quality Control. Join a collaborative international team at Grünenthal to enhance our pharmaceutical manufacturing standards.
Responsibilities
- 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
- 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
- International team with a powerful spirit of collaboration
- Equal employment opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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