Csv/pqm Lead

7 giorni fa


Bologna, Italia Red - The Global SAP Solutions Provider A tempo pieno

**RED GLOBAL - CSV/PQM LEAD-ITALY-12MONTHS+-ASAP START**

On behalf of a Key Client Partner I am currently searching for a CSV/PQM Lead to join an ongoing project delivering to an Life Sciences Client.
- Role: CSV/PQM Lead.Start: ASAP.Duration:12months+.Location: Hybrid - 3 or 4 days onsite per week onsite in Italy, Bologna.Capacity: 5 days a week.Languages: Italian
- 10 to 12 years of Professional experience and strong knowledge with Real Time experience in IT Quality & Compliance, Computer System Validation/Software Testing/System Implementation in the Life Sciences industry.
- Stakeholder management and good executor with required communication.
- Knowledge of Pharmaceutical/Life Sciences as domain.
- Experience to MES, QMS (Track wise), Lab solutions ie, LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc
- IT QMS
- Validation/Qualification
- Risk management.
- Handling of defects/Deviations
- Investigations
- CAPA Handling
- Test Management & Compliance

Hold accountability for authoring Validation Plan, and Validation Summary Reports and have fair understanding on other SDLC documents.

Well versed with Manufacturing, Quality and engineering system and their validations.
- OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)
- PAS/DCS Qualification
- ISA95 High level of understanding


  • Csv/Pqm Lead

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    BOLOGNA, Italia Red - The Global Sap Solutions Provider A tempo pieno

    **RED GLOBAL - CSV/PQM LEAD-ITALY-12MONTHS+-ASAP START**On behalf of a Key Client Partner I am currently searching for a CSV/PQM Lead to join an ongoing project delivering to an Life Sciences Client.- Role: CSV/PQM Lead.Start: ASAP.Duration:12months+.Location: Hybrid - 3 or 4 days onsite per week onsite in Italy, Bologna.Capacity: 5 days a week.Languages:...


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