Beschrijving vacature
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.
Profile:
- 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.
