Analytical Compliance Record Specialist

JETZT BEWERBEN DRUCKEN
LINK KOPIEREN

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

Analytical Compliance Record Specialist

Background:

Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, PTD actively collaborates and develops creative technical solutions to bridge early- stage, late-stage and commercial product needs. The mandate of the group is to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does. Synthetic Molecules Technical Development (PTDC) brings a broad range of experience across drug substance (DS), drug product (DP), analytical sciences and Manufacturing Science & Technology (MS&T), and collaborates closely with key partners in the departments Research and Early Development (pRED / gRED), Small and Large Molecules (PTC, PTB), PTD and MS&T across our manufacturing network. This position on offer is located in Analytical Development Synthetic Molecules withinPharma Technical Development.
Analytical Development is responsible for the development of resource and cost efficient analytical methods for all materials used during drug manufacturing using state of the art methodologies such as e.g. High-performance liquid chromatography (HPLC), Gas
Chromatography (GC), Ion Chromatography (IC), Mass Spectrometry (MS), and others. The ultimate goal of the work is a robust control strategy to release pharmaceutical products for clinical trials, and finally for commercial supply. The QC-Section within the Analytical Development Department is responsible for the Release of Materials based on the GMP compliant execution of Analyses of Inprocess controls, raw materials, intermediates, APIs and Drug products.

Tasks & Responsibilities:

  • Work in a modern quality control organization in compliance with cGMP regulations.
  • Management of Compliance Records for the department, mainly Deviations, Changes and CAPAs
  • Stakeholder management for the compliance record (including QA, Scientists, Senior Management)
  • Facilitation and Documentation of Root Cause Analyses
  • Active Participation in Quality Review Boards and other strategic and quality relevant governing bodies as needed
  • Inspection Support, including preparation and presentation of records to internal and external auditors / health authority inspectors
  • Critical evaluation of own work results
  • Key role in ensuring an appropriate GMP standard in the department
  • Scientific and regulatory documentation of the work done

Must Haves:

  • Advanced Degree: A university degree (Bachelor’s, Master’s, or higher) in a relevant Natural Science field (e.g., Chemistry, Pharmacy, Biology) 
  • Alternative Qualification: Candidates with a Laboratory Technician background will be considered if they possess over 10 years of high-level GMP experience
  • Between 3 to 5 years of professional experience within a regulated pharmaceutical or biotech environment
  • Proven, hands-on experience working under cGMP (current Good Manufacturing Practice) regulations is mandatory
  • QMS Software: Proficiency in Veeva Vault or a comparable Quality Management System (e.g., TrackWise) 
  • Core Competencies: Demonstrated ability in managing compliance records, specifically Deviations, Change Control, and CAPAs 
  • Business fluency is mandatory (written and spoken) for documentation and stakeholder management 
  • Proficiency in German is considered a strong asset and highly beneficial for internal communication

Nice to Have:

  • Roche Experience
  • Prior experience as a Deviation/CAPA Owner or previous experience in a Quality Assurance (QA) role

What you will be offered:

  • An opportunity to work in one of the world's most important pharmaceutical companies
  • Modern campus with plenty of green spaces and meeting areas
  • Central location in Basel
  • Varied job profile
  • Further training opportunities through temptraining
  • Working in a dynamic and motivated team

If you are interested please send your application documents addressed to Ms Diana Afonso.

Basel-Stadt Aargau Pharma Science Compliance GMP CAPA Deviation Change Control QA

JETZT BEWERBEN