CSV Quality Assurance Consultant (m/f/d)

We are looking for a motivated and committed Clinical Operations Lead (m/f/d) for our client, F. Hoffmann-La Roche Ltd. based in Basel, for a 12 month assignment with the option to extend.

The Quality Assurance (QA) oversight for global Pharmaceutical Technical Operations (PT) GMP Computerized Systems (CS) is implemented through a comprehensive, strategic, and risk-based methodology and framework. This ensures compliance with regulatory requirements and industry best practices across a wide landscape of validated IT systems critical to GMP operations. These systems support core business processes and must maintain a state of validated control throughout their lifecycle.

To ensure this, the QA responsibilities are shared and distributed within cross-functional teams-referred to as "Pods"-comprising specialists from Business Quality and IT. Each Pod is accountable for the continuous quality oversight of the systems in their scope, including operational support, change control, and validation lifecycle management. The collaboration within these Pods enables efficient decision-making and consistency across global IT landscapes.

Tasks & Responsibilities:

• Review IT computer system validation Deliverables as QA
• Review IT Change/Problem Tickets as QA
• Participate in other Quality Assurance Activities
• Functional Risk Assessments
• Test Plans and Reports
• Change Requests

Must Haves:

• BA/BS in Computer Science or equivalent experience in Industry (5-10 years)
• 5 Years experience in CSV
• IT skills required: Google Suite, Microfocus ALM, Veeva QMS is a +, Service Now
• Language skills: English Fluent and German would be a plus
• Soft skills required: calm, good negotiator, understanding of complex problem solving, understanding of GMP requirements

Benefits:

• Enjoy exclusive discounts all year round at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing a new car or receive consistent fuel discounts with our fuel card
• Be part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Work on a state-of-the-art campus with green spaces, social areas, and an inspiring atmosphere
• Take advantage of attractive fitness and swimming pool offers or use the gaming room as a creative retreat

Have we sparked your interest?

Don't hesitate and submit your complete application documents online today.

We look forward to hearing from you!

Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen - unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.

Kontakt
Adnan Ferizi

Arbeitsort
Basel

Pensum
100%

Position
Mitarbeiter

Branche
Projektleitung + Management