Overview
Quality Assurance (QA) Specialist (SAN015) Jobs in Brussels, Brussels Region, Belgium at Sansaone
Title: Quality Assurance (QA) Specialist (SAN015)
Company: Sansaone
Location: Brussels, Brussels Region, Belgium
Job Description
The role focuses on ensuring adherence to ISO/cGMP quality system standards and providing support to operations and quality control teams.
The QA Specialist will be responsible for making independent quality-related decisions and offering guidance to project teams through regulatory and compliance expertise.
This position requires the individual to oversee the quality aspects of the production process and perform audits to maintain the highest standards of quality and regulatory compliance.
Key Responsibilities
Ensure compliance with ISO/cGMP quality system requirements across the organization.
Provide on-the-floor QA support to operational and quality control staff.
Make independent decisions related to quality based on a strong understanding of regulatory and compliance requirements.
Conduct audits of internal quality system elements, focusing on manufacturing and operational support areas.
Requirements
Experience in QA within commercial drug substances/products, aseptic processing, or cell therapy manufacturing.
Strong knowledge of GMP compliance and Part 11 compliance.
Familiarity with international aseptic processing regulations.
Ability to work in a fast-paced, team-oriented environment and manage independent responsibilities.
Proficiency in Microsoft Office and database management tools.
Technical Skills
TrackWise
CAPA
Minitab
OQ
FDA
Autoclaving
Hiring Team Member
Avula Srivalli
Recruitment Coordinator
