Quality Systems & Compliance Specialist

Quality Systems & Compliance Specialist

An exciting opportunity has opened up for a Quality Systems & Compliance Specialist. In this role, you will be responsible for reviewing and ensuring that necessary Validations (aseptic simulations, process validation, and cleaning validation) are performed for manufactured products.

What You Will Do

Contribute with energy, knowledge, innovation, and leadership to:

As a Validation Technician:

• Execution of Validation activities (aseptic simulation, process/product, and cleaning validation).

As a Quality Systems Technician:

• Management of Events, CAPAs, and Change Controls (as a member of the Quality team).
• Creation/review/approval of documentation.
• Management of Quality information.
• Participation in internal, regulatory, and corporate audits.

What Skills You Will Need

To succeed in this role, you likely have:

• Bachelor's Degree in Health Sciences (preferably Pharmacy, Master's in Pharmaceutical Industry).
• Relevant professional experience in the pharmaceutical sector.
• Knowledge of the cleaning validation process.
• Proficiency in Spanish/Castilian.
• Advanced knowledge of English.
• Knowledge of validations.
• Regulatory knowledge in Good Manufacturing Practices (GMP) and applicable Pharmacopoeias.
• Knowledge in Document Systems.
• Advanced knowledge of Quality System tools (change controls, deviation management, out-of-specification results, CAPA management, validations, etc.).
• Knowledge of manufacturing processes for biological and sterile products is a plus.
• Experience in project participation, transfers, and audits is a plus.
• Experience in risk management, statistical tools, and continuous improvement methodologies is a plus.

Why Join Us?

As a company, we are committed to "Inventing for Life" in everything we do. We put the patient at the center and work to find solutions and treatments for some of the world's most complex health needs.

We pride ourselves on being a company that values diversity, talent, and commitment. Real innovation happens when different ideas meet in an inclusive environment.

If you are ready… apply today.

Key skills/competency

• Quality Systems
• Compliance
• Validation
• CAPA Management
• Change Control
• Auditing
• GMP
• Pharmaceutical Industry
• Documentation Management
• Regulatory Affairs