
IMP Quality Manager (m/f/d) Basel Temporär
posted 14 Stunden ago in Produktion Shortlist Email JobJob Detail
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Job ID 525592
Job Description
TemporärJobregion: Basel, SchweizStellenprozente: 80 – 100 %Industrie & ProduktionIMP Quality Manager (m/f/d)BeschreibungWe are looking for a motivated and committed IMP Quality Manager (m/f/d) for our client, F. Hoffmann-La Roche Ltd. based in Basel, for a 12 month assignment with the option to extend.IMP Quality Operations Switzerland ensures the delivery of Investigational Medicinal Products (IMPs) to patients in full compliance with current Good Manufacturing Practices (cGMP). As the dedicated Quality Partner for all Manufacturing Units and Clinical Packaging within Pharmaceutical Technical Development in Switzerland, we are responsible for overseeing Quality and Compliance across all relevant activities.Our mission is to foster an environment of experimentation and learning celebrating progress and coaching teams to build a purpose-driven quality community that brings innovative medicines to patients.We are looking for a flexible, resilient, and responsible professional to join our team. If you have in-depth GMP expertise combined with excellent interpersonal and negotiation skills, this role could be a great fit for you.Key Responsibilities
- Act as delegate of the Swiss Responsible Person (RP) for IMPs
- Ensure GMP compliance in the manufacturing and testing of IMP batches, especially for parenteral drug products
- Review and approve GMP-relevant documentation such as SOPs, master batch records, deviations, change controls, and validation reports
- Conduct internal GMP audits in production facilities and laboratories at Roche Basel
- Report directly to the RP and RP Deputy
Requirements
- Bachelor’s or Master’s degree in Life Sciences or a related field
- At least 3 years of experience in the pharmaceutical industry
- Minimum 3 years working in a GMP-regulated environment
- At least 3 years of hands-on experience in parenteral manufacturing and quality control
- Proven experience in a Pharmaceutical Technical Development setting
- Solid understanding of cGMP requirements for early-stage clinical development, especially for biotech and/or parenteral IMPs (e.g. EU Annex 1)
- Experience with discrepancy management, CAPA, technical change control (Veeva Vault), manufacturing systems (SAP), MES (PMX), and LIMS is a strong plus
- Fluency in English (C1) and German (C1), both written and spoken
What You Bring
- Quick learner and strong team player with a high degree of self-motivation
- Excellent time management and organizational skills; able to prioritize and multitask effectively
- Independent, result-oriented working style with the ability to simplify complexity and draw meaningful connections
- Analytical thinker with a creative and pragmatic approach to problem-solving
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.
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