Kerja Reliability Engineering Intern di Sanofi - Maukerja

About the Job

Reliability & Compliance Engineer Intern will be trained and exposed in the following responsibilities:

1. Equipment Requalification

• Plan, coordinate, and execute periodic equipment requalification activities (e.g., IQ/OQ/PQ as applicable).
• Review and update requalification protocols and reports to ensure compliance with GMP requirements.
• Liaise with Engineering, Production, and Validation teams to schedule requalification activities.
• Ensure calibration and validation status of equipment remains current and properly documented.
• Track requalification timelines and maintain requalification master schedules.

2. SOP Management & Updates

• Review and update Standard Operating Procedures (SOPs) to ensure alignment with current processes, regulatory requirements, and operational practices.
• Initiate document change requests (DCR) in accordance with the Quality Management System (QMS).
• Ensure proper version control, document approval workflows, and archival.
• Collaborate with cross-functional stakeholders to ensure SOP clarity and compliance.
• Support periodic document reviews to ensure documentation remains effective and compliant.

3. Compliance & Documentation

• Ensure activities comply with GMP and relevant regulatory standards.
• Support internal and external audits by preparing documentation and responding to audit queries.
• Assist in deviation investigations and CAPA implementation related to equipment or documentation gaps.

4. Annual Facility Review

• Conduct and document annual facility reviews to ensure compliance with GMP and regulatory requirements.
• Assess facility conditions, utilities, and environmental controls.
• Identify gaps and coordinate corrective actions where necessary.
• Ensure findings are documented and presented to management.

5. Annual Pest Control Review

• Review and assess annual pest control reports and monitor trends.
• Ensure pest control activities comply with site procedures and regulatory expectations.
• Liaise with pest control vendors to address findings or improvement areas.
• Maintain documentation for audit readiness

About You

• Degree or Diploma preferably in a related field

• Candidates from Polytechnic or University programmes are welcome to apply

• Strong organizational and time management skills with the ability to manage multiple tasks simultaneously

• Excellent written and verbal communication skills