Senior Quality Validation Analyst

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.