QA Validation Engineer [F / M / X]

Position Overview :

As a Validation Specialist, you will play a crucial role in ensuring that our healthcare manufacturing processes comply with current Good Manufacturing Practices (cGMP) and other relevant quality and compliance regulations. You will be responsible for the development, implementation, and execution of validation activities for small-scale equipment, ensuring that our systems maintain their validated status at all times.

Key Responsibilities :

• Demonstrate knowledge of cGMP requirements in a regulated environment and ensure compliance with relevant quality and compliance regulations.
• Troubleshoot validation issues effectively and provide solutions to maintain compliance.
• Develop, implement, and execute User Requirement Specifications (URS), System Impact Assessments (SIA), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Revalidation (RV) activities for small-scale equipment.
• Conduct hands-on validation studies for cGMP-critical process systems, ensuring compliance with user and regulatory requirements.
• Validate systems in scope, interpreting standards to fit specific cases in accordance with cGMP, cGLP, and Sanofi Procedures.
• Maintain the validated status of systems, ensuring ongoing compliance with cGMP at all times.
• Support projects in alignment with all required Sanofi and cGMP regulatory standards.
• Stay current on emerging validation regulations and testing practices to meet or exceed cGMP requirements.
• Provide technical assistance on current US FDA and EU validation requirements.
• Generate validation documentation, including protocols and reports, and assist with the execution of protocols for systems in scope.
• Oversee validation documentation through approval and implementation processes.
• Assess changes to determine their impact on validated status and validation documentation.

Qualifications :

What We Offer :

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.