As a Quality Assurance Intern, you play a key role in partnering with cross-functional teams in managing the GMP documentation lifecycle. You serve as a bridge between quality Systems and site operations ensuring that all GMP documentation is compliant at Sanofi Jurong.

Main Accountabilities

• Support to maintain quality agreements and technical specification with Third Parties outlining quality expectations and responsibilities.
• Supporting site's inspection readiness activities by providing relevant supports during internal audits and regulatory inspections (i.e., FDA and HSA)
• Support to draft and updating procedures, as well as generating reports and metrics related to compliance activities. Monitor monthly KPI for monitoring and reporting
• Support to manage the GMP documentation lifecycle (creation, revision, and obsolescence)
• Collaborating with other departments to ensure document content addresses the business needs and processes
• Ensuring, with the support of relevant experts that the documentation content is compliant with regulatory requirements and company standards
• Ensuring the overall documentation package is kept lean (i.e., avoiding redundancies and duplication)
• Ensuring accuracy, completeness, and compliance of the documentation with writing rules (incl. clarity and grammar)
• Collecting needs for documentation changes, prioritizing and managing document update
• Supporting the implementation of the documentation process with compliance to global documentation initiatives in term of simplification, harmonisation and digitalization.

Additional Accountabilities

• Support on follow up actions in GEMBA walk-down if required
• Play a proactive role by complying and adhering to HSE guidelines. Embrace Zero Incident Mindset and adopt the responsibility of HSE protection policies and Life Saving Rules (LSR).
• Other responsibilities that are not included in the above but related to quality assignments.

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.

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