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
Requirements
- More than 5 years of qualified 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.
Skills
Technical WritingQuality AssuranceGxPVeevaKneat
Benefits
- High-quality healthcare, prevention, and wellness programs
- At least 14 weeks of gender-neutral parental leave