About The Job

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 adaptable 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

Advantages
High-quality healthcare, prevention, and wellness programs
At least 14 weeks of gender-neutral parental leave

📌 Qualification And Validation Expert Report Issuance Hyderabad
🏢 Workowon
📍 Hyderabad