Our customer, a pharmaceutical company based in Basel, needs reinforcement. For a temporary employment (duration: 1 year) we are looking for a
Senior Quality Manager (m/f), 100%
Provide QA oversight on all external suppliers. Manage supplier qualifications, supplier changes, and quality agreements. Assure compliance to cGMP standards is maintained for third party management.
- Responsible for initiating and driving supplier qualifications
- Upgrade of supplier qualifications from clinical to commercial in scope of going commercial project
- Upgrade of raw materials and consumables from clinical to commercial in scope of
the going commercial project
- Oversight on all suppliers and raw materials used
- Manage quality aspects at external suppliers and ensure their compliance with good manufacturing practice
- Manage and evaluate change notifications from external suppliers
- Write GMP relevant documents in area of responsibility (SOPs, Quality Agreement, APS) and ensure implementation at third parties
- Perform local implementation of Quality Manual and global procedures (gap assessment, local changes in SOPs...)
In case of any question, please don't hesitate to contact Renato Imboden at 061 269 90 60.
Unser aktuelles Stellenangebot: www.edp-basel.ch / www.stellen-basel.net
- Minimum: Basic degree in scientific or relevant discipline (BS or equivalent)
- Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
- Fluent in English (oral and written) required; fluent in site-language desirable
- At least 3 years of relevant experience.
- Strong ability to negotiate and communicate.
- Good team working skills
- Sound scientific, technical and regulatory knowledge.
- Excellent knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
- Good knowledge of drug development and drug substance production.
- Good organizational skills.
- Good and proven ability to analyze and evaluate GMP compliance.