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On behalf of a Key Client Partner, I am currently searching for a CSV/PQM Lead to join an ongoing project delivering to a Life Sciences Client.
* Role: CSV/PQM Lead
Start: ASAP
Duration: 12 months+
Location: Hybrid - 3 or 4 days onsite per week in Bologna, Italy
Capacity: 5 days a week
Languages: Italian
The candidate is expected to demonstrate excellent core competence and experience in the delivery of IT CSV projects following Agile or DevOps methodology. The successful candidate shall possess:
* 10 to 12 years of professional experience with strong knowledge in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
* Stakeholder management and good communication skills.
* Knowledge of Pharmaceutical / Life Sciences as a domain.
* Experience with MES, QMS (Track wise), Lab solutions (i.e., LIMS, Empower CDS, Chromeleon), Business Analytics, Middleware, etc.
Candidate must have a fair conceptual understanding of the following key areas:
* IT QMS
* Validation/Qualification
* Handling of defects/Deviations
* Investigations
* Test Management & Compliance
Able to provide application validation expertise practically on different scenarios as applicable case to case (i.e., standalone/enterprise, etc.).
Hold accountability for authoring Validation Plans and Validation Summary Reports and have a fair understanding of other SDLC documents.
Well versed with Manufacturing, Quality, and Engineering systems and their validations.
Candidate must have an understanding of the latest regulations (i.e., 21CFR Part 11, EU annex 11) and guidelines (e.g., 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 tislam@redglobal.com for immediate consideration.
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