Quality Assurance Specialist (M/F)

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.

• Oversee quality compliance for assigned projects/products, aligning with cGMP standards.
• Foster a high-quality culture and drive continuous improvement initiatives.
• Engage directly with clients, addressing concerns and ensuring their requirements are met.
• Collaborate closely with production project teams to ensure cohesive execution and compliance.
• Prepare, review, and approve critical quality documentation and protocols.
• Conduct and support internal and external site audits, always ensuring we're inspection-ready.
• Monitor and manage deviations, proposing corrective actions (CAPAs) when needed.
• Update and approve SOPs, IOPs, and related documents.
• Address compliance challenges, coordinating solutions across departments.
• Emphasize health, safety, and environmental standards in all tasks.
• Maintain a presence on the manufacturing floor to ensure collaboration, oversight, and direct support.
• Lead and provide training initiatives for operational teams on cGMP and internal procedures.
• Analyze and address customer complaints in a timely manner.
• Make data-driven QA decisions and contribute to team KPI reporting.

• Mandatory university degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related.
• 3-5 years in a QA GMP role within the Pharmaceutical Industry preferred.
• Comprehensive knowledge of GMP practices and operational environments.
• Experience with or knowledge of Regulatory Affairs is a plus.
• Strong communication skills, both internally and with external partners, are highly valued.
• Fluency in English.
• Proficiency in MS Office.
• Exceptional documentation skills and attention to detail.

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.