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QA-QC Specialist - QA Manager
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Support
Projektbeschreibung
Exciting New Short Term position (8 Months, with possibility of extension) is available for a Quality Manager for one of my multi-national pharma clients based in Basel.
Responsibilities:
1. Support to manage quality aspects at external suppliers and ensure their compliance with good manufacturing practice (GMP) according to the relevant Standard Operating Procedures (SOPs).
2. Contribute/Write GMP relevant documents in own area of responsibility (eg, SOPs, Quality Agreement,) and deal with external stakeholders to implement quality document
3. Manage and evaluate change notifications from external suppliers
4. Responsible for driving/initiating Supplier Qualification (including management of change notification, periodic review)
5. Manage SOP life cycle in related tools in the electronic system (eg ESOPS).
6. Support the local Quality Organization in administrative and assigned compliance tasks
Education:
Minimum: Technician with continuing education (EU) or BS/MS (US) or equivalent
Basic Degree in scientific or relevant discipline (MS or equivalent)
Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
Languages: Fluent in English (oral and written), Good Knowledge in -site language (German)
Experience/Professional requirement:
1. At least 2 years of relevant experience in a regulated environment.
2. Scientific and GMPs knowledge
3. Good organizational skills.
4. Ability to negotiate and communicate.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Responsibilities:
1. Support to manage quality aspects at external suppliers and ensure their compliance with good manufacturing practice (GMP) according to the relevant Standard Operating Procedures (SOPs).
2. Contribute/Write GMP relevant documents in own area of responsibility (eg, SOPs, Quality Agreement,) and deal with external stakeholders to implement quality document
3. Manage and evaluate change notifications from external suppliers
4. Responsible for driving/initiating Supplier Qualification (including management of change notification, periodic review)
5. Manage SOP life cycle in related tools in the electronic system (eg ESOPS).
6. Support the local Quality Organization in administrative and assigned compliance tasks
Education:
Minimum: Technician with continuing education (EU) or BS/MS (US) or equivalent
Basic Degree in scientific or relevant discipline (MS or equivalent)
Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
Languages: Fluent in English (oral and written), Good Knowledge in -site language (German)
Experience/Professional requirement:
1. At least 2 years of relevant experience in a regulated environment.
2. Scientific and GMPs knowledge
3. Good organizational skills.
4. Ability to negotiate and communicate.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges