Validation Senior [F/M/X]

工作内容

Job Description

Job description

Join our team and start a new adventure in an international and dynamic environment where you will fulfill your career aspirations in a fast-growing organization.

Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in the biopharmaceutical industry while acting as an ambassador of our organization to clients through:

• Building strong, trust-based relationships.
• Displaying curiosity and continuous learning to solve complex challenges for our global clients.
  

Your missions

• Ensure QA oversight in validation activities such as IQOQ, PQ, and PV.
• Review and approve validation documentation in compliance with GMP standards and Vaccines procedures.
• Align production practices with validation conclusions and attend project meetings as a QA validation representative.
• Escalate critical issues during validation and contribute to the deviation process by providing QA oversight and approval for validation-related deviations.
• Proactively identify quality and compliance risks, managing them via risk registers and quality plans.
• Define validation strategies through the change control process and author validation documentation (e.g., Validation Plans, Summary Reports, Risk Assessments, Gap Analyses).
• Support production, QA, and technical service teams in validation activities and improvement plans.
  

Your profile

• Relevant industrial experience in validation and QA within the biopharmaceutical industry.
• Knowledge of GMP standards, CFR regulations, and Eudralex guidelines.
• Familiarity with validation-related regulations and standards.
• Proficiency in French and English (written and spoken).
• Strong interpersonal skills, problem-solving abilities, and a team-oriented mindset.
• Capability to apply a risk-based approach to problem-solving and prioritize tasks.
• Demonstrated sense of urgency in delivering quality outcomes.
  

What We Offer

• An international community bringing together 110+ different nationalities.
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities.
• A robust training system with our internal Academy and 250+ available modules.
• A vibrant workplace with regular internal events (afterworks, team buildings, etc.).
• Strong commitments to CSR, notably through participation in our WeCare Together program.
  

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.