Analytical Compliance Record Specialist
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, with vital research and development functions based here. We are seeking an experienced Analytical Compliance Record Specialist for our long-term client, F. Hoffmann-La Roche AG in Basel.
Background:
Global Technical Development (PTD) consists of over two thousand professionals worldwide, playing a crucial role in Roche's mission to develop meaningful medicines for patients. PTD actively collaborates to create innovative technical solutions that address product needs at various stages, including early-stage, late-stage, and commercial phases. The group is dedicated to delivering a reliable pipeline and supplying quality products to patients. Our commitment to excellence is driven by innovation, teamwork, dedication, and mutual respect, leading to continuous improvements in our processes.
The Synthetic Molecules Technical Development (PTDC) unit brings extensive experience in drug substance (DS), drug product (DP), analytical sciences, and Manufacturing Science & Technology (MS&T). We collaborate closely with key partners within the Research and Early Development (pRED/gRED) divisions and our manufacturing network. This role is situated in the Analytical Development Synthetic Molecules framework within Pharma Technical Development, where our focus is on developing resource-efficient and cost-effective analytical methods. We employ state-of-the-art methodologies such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ion Chromatography (IC), and Mass Spectrometry (MS). The primary objective is to establish a robust control strategy for the release of pharmaceutical products for clinical trials and commercial supply. The QC section within Analytical Development is tasked with releasing materials based on GMP-compliant analyses of in-process controls, raw materials, intermediates, APIs, and drug products.
Tasks & Responsibilities:
- Work within a modern quality control organization, adhering to cGMP regulations.
- Manage compliance records for the department, including Deviations, Changes, and CAPAs.
- Engage in stakeholder management for compliance records, collaborating with QA, scientists, and senior management.
- Facilitate and document root cause analyses.
- Participate actively in Quality Review Boards and other strategic quality governing bodies as required.
- Support inspections, including the preparation and presentation of records to internal and external auditors and health authority inspectors.
- Critically evaluate your work results.
- Play a key role in upholding GMP standards within the department.
- Create scientific and regulatory documentation for all work performed.
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.
- 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.
- Proficiency in QMS Software, specifically Veeva Vault or a comparable Quality Management System (e.g., TrackWise).
- Demonstrated ability in managing compliance records, specifically Deviations, Change Control, and CAPAs.
- Business fluency in English (written and spoken) is required for documentation and stakeholder management.
- Proficiency in German is a strong asset and highly beneficial for internal communication.
Nice to Have:
- Experience working with Roche.
- Prior experience as a Deviation/CAPA Owner or in a Quality Assurance (QA) role.
What You Will Be Offered:
- An opportunity to work in one of the world's leading pharmaceutical companies.
- A modern campus with ample green spaces and meeting areas.
- Central location in Basel.
- A varied job profile with diverse responsibilities.
- Further training opportunities through temptraining.
- Collaboration within a dynamic and motivated team.
If you are interested, please apply online using the form below. Only applications matching the job profile will be considered.