Quality Assurance Associate

Join a Market Leader:
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.

You will be responsible to:
Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle.

Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.
- Manage quality activities to ensure compliance with cGMP and legal regulations, keeping the site audit-ready.
- Promote high-quality standards and foster a culture of continuous improvement across company operations.
- Prepare for and support internal and external audits, ensuring consistent inspection readiness.
- Prepare, review, and approve SOPs, IOPs, protocols, reports, and regulatory documentation as needed.
- Participate in key quality activities for assigned projects and new product introductions.
- Monitor and ensure timely closure of deviations and approval of change controls (PdAs).
- Facilitate effective communication between stakeholders and support compliance issue resolution.
- Maintain regular presence in manufacturing areas, providing hands-on support and fostering collaboration.
- Investigate customer complaints and support the generation and reporting of team KPIs.
- Ensure safe practices and compliance with HSE standards in all assigned tasks and responsibilities.
- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory)
- Requires educational / training experience in a QA GMP environment within the Pharmaceutical Industry (desirable)
- Experience of working in a GMP operational environment (desirable)
- Training and experience of GMP standards (desirable)
- Experience of working with Regulatory Affairs and a basic knowledge of the function (desirable)
- Knowledge of GMP practices
- Fluency in English is a requirement
- Computer literate with good working knowledge of the MS Office package
- Good documentation skills and attention to detail
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

**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.

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