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.
