In brief 📌

Position: QA Responsible
Location: Montevideo - Zona Franca
Experience: 4+ years in similar roles within the pharmaceutical industry
Contract: Permanent

Want to know more? 👇

Exeltis is the branded business unit of Insud Pharma, an international pharmaceutical group operating across the entire value chain, with a strong commitment to innovation, operational excellence, and sustainable development.

With a global presence and a firm focus on health and wellbeing, at Exeltis we work to bring high-quality therapeutic solutions to patients worldwide, driven by talent, collaboration, and continuous improvement.

We are currently looking for a QA Responsible based in Montevideo - Free Trade Zone, a strategic role focused on ensuring compliance with the highest quality standards in an international pharmaceutical environment.

What are we looking for? 🔎

We are looking for a professional with solid experience in Quality Assurance within the pharmaceutical industry, who will ensure compliance with current GxP, applicable national legislation, regulatory requirements, and internal quality standards.

This role will be key in the implementation, maintenance, and oversight of the Pharmaceutical Quality Management System (QMS) related to GDP and GMP activities, in alignment with Insud Pharma global quality policies.

In addition, this person will act as the main contact with Local Health Authorities and as Responsible Person (RP) for wholesale authorization and Qualified Person (QP), where applicable.

The challenge! 🚀

Your main responsibilities will include:

• Ensuring compliance with current GxP, applicable national legislation, regulatory requirements, and internal quality standards.
• Acting as the main point of contact with Local Health Authorities.
• Acting as Responsible Person (RP) for wholesale authorization and as Qualified Person (QP), where applicable.
• Developing and maintaining the full Pharmaceutical Quality Management System (QMS) related to GDP and GMP activities, in direct coordination with the Global Quality Assurance department.
• Overseeing the creation, implementation, and maintenance of the Quality System.
• Ensuring that critical GxP activities are properly performed, including:
  • deviation management,
  • risk management,
  • change control,
  • training,
  • delegation documentation.
• Managing returns, recalls, and quality complaints.
• Leading supplier qualification activities.
• Coordinating initial and ongoing GxP training for personnel.
• Developing and reporting quality metrics to monitor Quality System performance.
• Managing internal and external GDP/GMP audits.
• Collaborating cross-functionally with other departments and business partners, especially:
  • Regulatory Affairs,
  • Business Development,
  • Supply Chain,
  • Launch Management.
• Overseeing and qualifying the Free Trade Zone or other physical importation sites, where applicable.
• Ensuring batch certification for release, verifying that each batch meets the required quality standards, where applicable.
• Ensuring transportation documentation is properly verified.
• Ensuring the availability of original Certificate of Conformance / Certificate of Analysis (CoC/CoA) documentation.
• Collecting, prioritizing, coordinating, and supporting global quality activities and strategic initiatives across affiliates and subsidiaries, as needed.

What do you need? 🤓

To succeed in this role, we are looking for a professional with:

• A degree in Pharmacy, Pharmaceutical Chemistry, or equivalent.
• A Master’s degree will be considered a plus.
• 4+ years of experience in similar roles within the pharmaceutical sector.
• Previous experience in international environments.
• Strong knowledge of GDP/GMP standards, including their interpretation and practical application.
• Fluent Spanish and English.
• Additional languages will be considered an asset.
• Availability to travel up to 30%.

Personal skills

We are also looking for someone with:

• Strong leadership skills.
• A high level of strategic thinking.
• Excellent organizational skills.
• Strong communication abilities.
• Ability to work effectively in cross-functional and international environments.

🔷 Do you think this opportunity is not for you? 🔷

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Equal Opportunity Commitment

At Exeltis, we are committed to fostering a diverse, inclusive, and equal opportunity workplace. All applications will be considered without regard to gender, gender identity or expression, age, ethnic or social origin, religion, sexual orientation, disability, or any other characteristic protected by applicable law.