Quality Assurance Specialist

Overview

In this role you ensure product quality and regulatory compliance within Sanofi’s Manufacturing & Supply network. You will coordinate and own quality systems, inspections, and deviations to support reliable, safe medicines at scale. You’ll interact with cross-functional teams to implement global standards and drive quality improvements. This is a hands-on position with a focus on end-to-end quality governance and continuous improvement, aligned with Sanofi’s mission to deliver life-changing treatments.

Responsabilità

Manage and coordinate Quality Systems, including Product Quality Reviews, Change Control, Deviation, Market Complaint, OOS/OOT, Training, and CAPA systems

Coordinate Subcontractor/Service Provider QA activities and ensure alignment with global standards (STDs and GOPs)

Oversee Validation systems (Process, cleaning, transport, computerized systems) and Calibration document reviews

Perform batch release support and respond to QP queries; ensure data integrity and audit trail review

Lead c

GMP document control, training coordination, and self-inspection activities

Act as Primary Process Owner for Quality Maturity Index (QMI) and support SMS and HSE initiatives

Oversee Site Master File, instrument checks, and documentation archival/retrieval

In-Process Quality Assurance tasks including Master Batch Records review, line clearance, and on-floor quality oversight

Temperature/Humidity mapping, hold time studies, and validation/qualification focal points

HSE adherence, safe working conditions, and zero-risk safety initiatives

Review and approve manufacturing records and logbooks; ensure proper documentation control and access management

Support for Market Complaints investigations and CAPA implementation

Batch release processing and data integrity related activities

Quality oversight of shopfloor and routine production sampling

Requisiti fondamentali

2 to 5 years of experience in QA/QC environments

Experience in IPQA, Batch Record Review, and Shopfloor Quality Governance

B.Pharm or M.Pharm

Languages: English, Hindi, Konkani, Marathi

3-shift work availability

attention to detail

cross-functional collaboration

problem-solving orientation

IPQA

Batch Record Review

Shopfloor Quality Governance