Quality Assurance Specialist
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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.
- 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 cGMP 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
- 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
- 3-shift work availability
- cross-functional collaboration
- problem‑solving orientation
- IPQA
- Batch Record Review
- Shopfloor Quality Governance
Quality Assurance Specialist bolzano, trentino alto adige, it
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