Quality Assurance Specialist Hovione Tejo

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About Hovione

At Hovione, we help partners turn scientific innovation into medicines that reach patients around the world. For more than 65 years, we have connected science, technology, and manufacturing to scale complex ideas into high-quality and innovative solutions that truly make a difference.

As an international Contract Development and Manufacturing Organization (CDMO), we support the development and manufacture of drug substances, intermediates, and drug products across the full life cycle. We are globally recognized for our leadership in specialized technologies such as Spray Drying and Continuous Tableting. But what truly sets us apart is not just what we do — it is how we do it: with purpose, care, collaboration, and a deep commitment to doing the right things right.

Our people are the reason for our success. We are a global and diverse team of more than 2,600 team members across Europe, the USA, and Asia, bringing together different experiences and perspectives to help our partners to overcome complex challenges. We believe that an inclusive environment — where everyone, regardless of background, identity or ability, is respected, heard and empowered to contribute — is essential to drive innovation, ensure quality, and secure long‑term sustainable success.

And as we grow, so do the opportunities for our people to develop, broaden their perspectives, and build meaningful careers. Because at Hovione, better starts with those who choose to make a difference every day. Will you be one of them?

You will be responsible to:

• Ensure all assigned products, projects, and quality activities are managed in full compliance with cGMP requirements, regulatory expectations, and internal quality standards;
• Support the maintenance and continuous improvement of the Quality Management System (QMS), ensuring processes remain effective, compliant, and audit-ready;
• Lead and support key quality activities including change controls, deviations, CAPAs, quality risk assessments, validation activities, product reviews, and new product introductions;
• Review, prepare, and approve quality-related documentation, including SOPs, protocols, reports, batch documentation, specifications, and quality agreements;
• Monitor, investigate, and facilitate the closure of deviations, non-conformances, and quality events, ensuring timely implementation of corrective and preventive actions;
• Coordinate and support internal audits, client audits, regulatory inspections, and inspection readiness initiatives across the site;
• Collaborate with Manufacturing, Quality Control, Regulatory Affairs, Procurement, and external suppliers to ensure compliance and effective quality oversight;
• Provide quality oversight on manufacturing operations through regular presence on the production floor, ensuring adherence to GMP requirements and best practices;
• Support supplier qualification activities and ensure the quality of materials, components, and services throughout the supply chain;
• Drive continuous improvement initiatives, deliver quality-related training, and promote a culture of compliance, quality excellence, and operational effectiveness.

We are looking to recruit a Candidate:

• University degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or another relevant scientific discipline;
• 3–5 years of experience in a Quality Assurance role within a GMP-regulated pharmaceutical environment;
• Practical experience working in pharmaceutical manufacturing or quality operations under GMP requirements;
• Strong knowledge of GMP regulations, quality systems, and pharmaceutical compliance standards (mandatory);
• Experience managing quality processes such as deviations, CAPAs, change controls, audits, validation, and documentation review;
• Familiarity with Regulatory Affairs processes and regulatory submissions is considered an advantage;
• Fluency in English, both written and spoken;
• Strong documentation, organizational, analytical, and problem-solving skills, with proficiency in Microsoft Office applications.

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. We are committed to creating an inclusive recruitment experience and welcome applications from all qualified candidates. If you require any reasonable accommodation or support during the application or interview process, please contact us, and we will be happy to assist.

Notice to Agencies and Search Firms Representatives

Hovione does not accept unsolicited resumes from agencies or search firms for this job posting. Any resumes submitted to Hovione by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Hovione. No fees will be paid if a candidate is hired for this position as a result of an unsolicited referral.