Quality Assurance Intern

Sanofi; Singapore; On-site; SGD 18,000 - 24,000; Part time

Job summary

Sanofi Jurong seeks a Quality Assurance Intern to collaborate with cross-functional teams on GMP documentation lifecycle. You will bridge quality systems and site operations to ensure compliant GMP documentation at the Jurong site.

You will support audits, procedures drafting, KPI reporting, and document management while contributing to simplification and digitalization efforts within global documentation initiatives.

Qualifications

• Hands-on exposure to GMP documentation lifecycle and quality systems.

Responsibilities

• Support to maintain quality agreements and technical specifications with Third Parties outlining quality expectations and responsibilities.
• Support site inspection readiness activities during internal audits and regulatory inspections (FDA and HSA).
• Draft and update procedures, generate reports and metrics related to compliance activities; monitor monthly KPI.
• Manage the GMP documentation lifecycle (creation, revision, obsolescence).
• Collaborate with departments to ensure content meets business needs and processes.
• Ensure documentation content complies with regulatory requirements and company standards.
• Keep documentation lean, avoid redundancies and duplication.
• Ensure accuracy, completeness and writing quality (clarity/grammar).
• Collect needs for documentation changes, prioritize and manage updates.
• Support implementation of documentation processes with global simplification, harmonisation and digitalization.

Skills

Quality Assurance

Documentation

Regulatory compliance

GMP

Inspection readiness

KPI reporting

Job description

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.