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

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