CSV/PQM Lead

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

The candidate is expected to demonstrate excellent core competence and experience in delivery of IT CSV projects following Agile or DevOps methodology. The successful candidate shall possess:

• 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

Candidate must have fair conceptual understanding on below key area;

• IT QMS
• Validation/Qualification
• Risk management.
• Handling of defects/Deviations
• Investigations
• CAPA Handling
• Test Management & Compliance

Able to provide an application validation expertise practically on different scenarios as applicable case to case ie, standalone/enterprise etc.

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.

Candidate must have understating on latest regulations ie, 21CFR Part 11, EU annex 11, and Guidelines eg, GAMP5 guide.

• OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)
• PAS/DCS Qualification
• ISA95 High level of understanding

If you are interested and available, please apply or send an email to (see below) for immediate consideration.