QA Responsible – Pharmaceutical Quality Management

About the role

Exeltis, the branded business unit of Insud Pharma, is looking for a QA Responsible based in Montevideo, Free Trade Zone. This is a permanent position focused on ensuring compliance with the highest quality standards in an international pharmaceutical environment. The role is central to implementing, maintaining and overseeing the Pharmaceutical Quality Management System (QMS) for GDP and GMP activities, and acts as the main contact with local health authorities.

Key responsibilities

• Ensure compliance with current GxP, national legislation, regulatory requirements and internal quality standards
• Act as the main contact with Local Health Authorities and as Responsible Person (RP) for wholesale authorization and Qualified Person (QP), where applicable
• Develop and maintain the QMS for GDP and GMP activities in coordination with the Global Quality Assurance department
• Oversee critical GxP activities such as deviation management, risk management, change control, training and delegation documentation
• Manage returns, recalls and quality complaints; lead supplier qualification
• Coordinate GxP training and report quality metrics
• Manage internal and external GDP/GMP audits
• Collaborate with Regulatory Affairs, Business Development, Supply Chain and Launch Management
• Qualify Free Trade Zone or other importation sites, verify batch certification, transport documentation and CoC/CoA availability
• Support global quality activities across affiliates and subsidiaries

Required profile

• Degree in Pharmacy, Pharmaceutical Chemistry or equivalent; a Master's degree is a plus
• 4+ years of experience in similar roles within the pharmaceutical sector
• Previous experience in international environments
• Fluent Spanish and English; additional languages are an asset
• Availability to travel up to 30%

Required skills

• Strong knowledge of GDP/GMP standards, including their interpretation and application
• Leadership, strategic thinking, organization and communication skills
• Ability to work in cross-functional and international settings