Quality Systems Specialist

Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

As a Qualification & Validation Specialist, you will play a key role in ensuring that our facilities, equipment, and systems are fit for purpose and compliant with applicable quality standards. You will work cross-functionally to define and implement best practices in qualification and validation, supporting both local and global initiatives.

🔑 Key Responsibilities

• Ensure cGMP compliance before, during, and after qualification/validation activities.
• Validate systems, equipment, and processes according to intended use and product requirements.
• Support continuous improvement and promote a quality-driven culture.
• Align qualification and validation procedures across Hovione sites.
• Collaborate with Engineering, Maintenance, Production, and Quality Control to ensure system compliance.
• Participate in project design reviews to ensure GMP compliance.
• Develop and approve validation protocols, VMPs, and related documentation.
• Support audits and inspections, and manage deviations, CAPAs, and change controls.
• Provide training and contribute to the development of quality system methodologies.
• Ensure safe work practices and compliance with HSE and GMP guidelines.

🎓 What We’re Looking For

Education & Experience:

• University degree in Chemistry, Chemical Engineering, Mechanical Engineering, or a related scientific field (mandatory).
• 3–5 years of experience in Qualification & Validation, preferably in a GMP-regulated environment.

What We’re Looking For

Education & Experience:

• University degree in Chemistry, Chemical Engineering, Mechanical Engineering, or a related scientific field (mandatory).
• 3–5 years of experience in Qualification & Validation, preferably in a GMP-regulated environment.

Technical Skills:

• Strong knowledge of cGMP, ICH, ISO guidelines, and risk assessment methodologies.
• Experience with process and HVAC systems is a plus.
• Fluent in English; proficient in MS Office.

Soft Skills:

• Strong problem-solving and decision-making abilities.
• Ability to work independently and collaboratively.
• Excellent communication and documentation skills.

🤝 Why Join Us?

• Be part of a mission-driven organization that values quality, innovation, and collaboration.
• Work in a dynamic, high-impact environment with opportunities for growth.
• Contribute to global projects and continuous improvement initiatives.

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.