Csv/Pqm Lead BOLOGNA

Csv/Pqm Lead
Bologna
Emilia Romagna, BOLOGNA

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