Qualification and Validation Expert - Report Issuance

Global Manufacturing and Supply Services at Sanofi is responsible for delivering and supporting Global M&S teams. The Qualification and Validation Report Issuance team is responsible for authoring facilities, utilities, and equipment qualification documents.

Key Responsibilities

• Perform comprehensive content and technical writing and reviews to ensure accuracy, completeness, and compliance against approved templates and protocols.

• Review for accuracy and completeness of all data in protocols and reports while aligning documentation standards with global Quality requirements.

• Ensure equipment qualification activities comply with Quality regulations and pharmaceutical practices, summarizing key findings.

• Perform report signing in Veeva CMS or Kneat.

• Translate and adapt protocol and report communications for sites and hubs ensuring clarity and alignment.

• Monitor and track execution of activities against defined timelines to achieve established KPI targets.

• Ensure full compliance with GxP principles, regulatory requirements, and Sanofi Quality standards.

• Drive continuous improvement initiatives through standardization, simplification, and digitalization of equipment qualification processes.

Requirements

• More than 5 years of professional experience in qualification.

• Proficient in problem-solving, attention to detail, and good organizational skills.

• Ability to work collaboratively with cross-functional teams in a flexible and proactive manner.

• Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related field.

Preferred Qualifications

• Advanced degrees such as MSc or PhD.

• Experience with Veeva and Kneat quality systems.

• Communication skills in French or other languages in addition to English.