Quality System Manager
Sanofi
Posted 30+ days ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
Main responsibilities
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Implements a common document architecture for all Hubs by applying the Global Quality model.
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Implementation of the Quality system common to all Hubs (SOP, instructions, Protocol)
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Implementation of the group's electronic tools for Quality management (software, application)
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Provide the necessary support for user training on the Quality system (SOP, instructions) & Electronic Tools
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Ensure documentary monitoring following changes in regulations
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Perform gap analysis between local and global documents
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Maintain the Hubs’ Document Quality system in accordance with Corporate documents.
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Define corrective action plans related to deviations identified in the documentation and ensure their implementation.
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Implement performance indicators for monitoring the Quality activity of the Hubs
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Ensure cross-functional interactions with Hubs, communication on changes made to documents, their implementation date.
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Review of user access management to applications and software.
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Participate in operational Quality activities (establishment of quality contracts with subcontractors, management of deviations and CC linked to the department's activity.
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Provide support to Hubs during internal quality audits.
Education level
Scientific training (Pharmacist, Engineer) or equivalent Bac + 5 minimum & master's degree in Quality management
Experience required
4 years minimum in Quality Systems Management (documentation & Systems)
Required knowledge
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Good knowledge of GMP, EU regulations, WHO standards
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Good knowledge of the pharmaceutical environment
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Quality Management of Subcontracting Activities
Comp tences techniques
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Ability to write documents (SOP, Protocol, Report, etc.)
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Good computer skills (software, Excel, PowerPoint)
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Good command of English (written and spoken)
Comp tence g n rales
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Ability to learn quickly and develop autonomy
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Ability to communicate effectively and efficiently with other functions.
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Ability and flexibility to work with multifunctional and multicultural teams
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Ability to solve problems proactively
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Ability to effectively manage multiple priorities simultaneously
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn t happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Quality
- Testing
- QA
- QC
- Inspector
Keywords
- Quality System Manager
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