Hovione is a 60 years Portuguese multinational company. 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 organization (CDMO) offering from drug substance to drug product intermediate to drug product.
Hovione recognizes that people are the main asset for the company’s continued success, reaching over 1700 team members, from 20 different nationalities located in Portugal, US, Macao, Ireland, Hong Kong, Japan, India and Switzerland, including several production sites.
In 2019, we were recognized as the third most attractive company to work for in Portugal.
Working at Hovione means reaching for innovation and excellence in everything we do : for ourclients, our partners and, above all, our patients.
As part of the Quality Life Cycle Management team, the Product Lifecycle Specialist will be responsible for the management of a product’s lifecycle (from concept creation, through design and manufacture, until product / Project discontinuation).
This person will also be responsible for the implementation us of Quality Risk Management (QRM) applied in Process Validation / Process Performance Qualification (PV / PPQ), so that the organization is able to capture, manage, report and mitigate risks throughout the product’s lifecycle.
Main responsibilities :
Develop, set and implement PV / PPQ and continued process verification procedures using QRM tools;
Ensure compliance with the standards set for product lifecycle in all Hovione's sites;
Oversee validation status of the products, looking for trends, improvements and rationalization of activities;
Encourage the use of modern pharmaceutical technologies and tools, by participating in its implementation with other areas / departments;
Improve the quality system, either by including new methodologies or by standardizing and simplifying procedures and practices;
Promote suitable interactions with Quality Assurance local / site teams to implement the best PV / PPQ practices and QRM activities, across the company;
Keep the area up to date with PV / PPQ / QRM guidelines, ensuring internal training and documentation revision;
Be present at Regulatory Inspections and Customer Audits.
University degree in Chemistry, Chemical Engineering or equivalente degree in a scientific area;
Preferably 3 years of experience in an operational area (e.g., Research & Development or Manufacturing);
Experience in working in a Good Manufacturing Practice (GMP) environment;
Solid knowledge of guidelines regarding GMP, International Conference on Harmonisation (ICH), Food and Drug Administration (FDA) and Eudralex;
Knowledge of Process Validation / Process Performance Qualification and Quality Risk Management tools and methodologies will be a factor of differentiation;
English fluency (written and oral);
Good communication skills and strong team spirit;
Proactive and dynamic attitude;
Focus on accuracy, responsibility and organization.
We offer :
Full time opportunity;
Remuneration and social benefits adjusted to the job function and matching the experience;
Excellent work environment, with a strong focus on quality.