Senior Quality Validation Analyst

Basel  ‐ Vor Ort
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Beschreibung

Senior Quality Validation Analyst - GMP / CSV / ALM / English

Role: For our client in the Pharma industry based Basel region We are looking for a senior candidate who has his focus of experience in Quality and Validation with a background of manufacturing and knows the mentioned software's in the must have criteria's. The experience should come from a pharmaceutical, biotech or at least GMP environment.

Background: In this position, you will work in the global quality unit. The team works closely and

collaboratively with IT testing and Business collaborates in delivering and maintaining

Validated Computerized Systems.
Tasks & Responsibilities:
  • Creating and/or reviewing risk assessments, validation plans and reports
  • Providing validation and Compliance advice and guidance to project managers, project
  • team, and IT Validation Leads
  • Reviewing and approving change controls
  • Periodically reviewing computer systems, creating/revising, and action annual quality plans
  • Assisting in Regulatory Inspections and Corporate Quality Audits
  • Preparation of project-based documentation for computerized system
  • Responsible for reviewing documents and approving Validation Documents with a focus on
  • LEAN CSV/CSA processes
  • Support IT and Quality while discussing CSV strategy
  • Providing support and guidance to the global network for Discrepancy and CAPA resolution


Must Haves:
  • Bachelor degree in Computer Science or any similar
  • 5-7 years of experience in IT Quality/Validation for the GMP area
  • Sound intermediate-level knowledge of Computer System Validation Standards and Processes, including data integrity and data life cycle, computer system change control, testing, and the handling of deviations
  • Intermediate knowledge of FDA 21 CFR Part 11, EU GMP Vol 4 Annex 11, GAMP 5.0
  • Proficiency in EDMS, ALM Software (HPALM), Service NOW, Google Suite
  • Fluency in English, German is a plus
  • Root cause analysis and problem-solving skills
  • Ability to take efficient and effective decisions within a reasonable timeline
  • De-escalation skills
  • Strong organizational and technical writing and verbal communication skills


Nice to Haves:
  • Previous Roche IT or Quality Validation experience
  • Advanced Analytics (ML/AI) experience
  • Agile experience (e.g. Scrum or SAFe 5.0)
  • ITIL Processes experience

Reference no: 921533SKN

Role: Senior Quality Validation Analyst

Industry: Pharmaceutical industry

Workload: 100%

Location: Basel, Switzerland

Start date: July 2022

Duration: 12+ months (Extension possible)

About us: ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.
Start
06/2022
Dauer
6++
(Verlängerung möglich)
Von
ITech Consult AG
Eingestellt
19.05.2022
Projekt-ID:
2388780
Vertragsart
Freiberuflich
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