GMP Compliance Specialist 80-100% (m/f/d)

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Background:

The goal of Roche’s Pharmaceutical Research and Early Development organization (pRED), is to make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, the employees are united by their mission to transform science into medicine. Together, they create a culture defined by curiosity, responsibility and humility, where talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.

This position is located in Preclinical Chemistry, Manufacturing, and Controls (pCMC), a department within the Small Molecule Research organization in pRED Therapeutic Modalities (TMo), where the team paves, in a diverse, ambitious and innovative environment, the path to bring drug candidates from early research into development. The teams collaborates actively with the discovery and development partners functions providing cutting-edge technologies and scientific excellence to transform molecules into future medicines.

Tasks & Responsibilities:

• Management of local and global compliance processes like GMP training, archiving, quality risk management, handling of multisite and local impact assessments
• Being an expert and first level support for relevant quality systems (e.g. Cornerstone, Veeva OneQMS, QualityDocs, QRM,)
• Managing changes and deviations, as well as corrective and preventive actions in consultation with QA
• Provide expert support to monitor, update, and adapt the GMP-relevant document landscape within pCMC
• Participating in the preparation and coordination of internal and health authority audits, as well as supporting the timely implementation of inspection findings
• Collaborating with team members in a role based working environment, as well as building and growing relationships with customers and partners across functional boundaries

Must Haves:

• Bachelor or equivalent and/or higher degree in chemistry, biology or pharmaceutical sciences
• Operational experience in a GMP environment within the pharmaceutical industry
• MS office / standard Google applications
• Fluent in German, good verbal and written communication skills in English
• Soft skills: detail-oriented and analytical mindset; ability to identify potential deficiencies, propose solutions, and effectively interpret and apply regulatory requirements; excellent communication skills; ability to collaborate efficiently with interdisciplinary teams in a dynamic environment

Nice to Have:

• Experience in synthetic molecule manufacturing and/or quality control, as well as knowledge of GMP regulations
  (e.g., ICH Guidelines) and principles of quality systems is a plus

Our offer:

• A modern workplace with many social- and green zones
• Fair compensation with 2 days / week home office possibilities
• Familiar motivated team
• The ability to work for a company who works towards creating a positive impact on patients livelihood

We look forward to receiving your complete application documents addressed to Ms Marica Hug.

Basel City Vollzeit Fulltime Basel-Stadt Compliance Experte / Expertin Compliance Specialist