Product Lifecycle Specialist

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.