- To develop, set and implement Process Validation/Product Performance Qualification (PPQ) and Continued Process Verification (CPV) procedures using Risk Management tools.
- To oversight Validation status of Hovione's products looking for improvements and rationalization of activities. To establish and monitor product performance indicators and analyze trends.
- To assure compliance with the standards set for Product Lifecycle in all Hovione's Sites.
- To improve Hovione's Quality System either for including new methodologies, modern pharmaceutical technologies implemented or for standardizing and simplifying procedures and practices.
- To open and maintain active and efficient communication channels with each Site QA in order to implement the best practices, across Hovione.
- To keep the area up to date with Process Validation (PPQ)/QRM , and Cleaning guidelines, assuring internal training and documentation revision.
- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmacy or similar scientific field (mandatory)
- 2-3 training experience in operational areas (e.g., Quality Control, Quality Assurance, Manufacturing, R&D, Engineering) preferably within the Pharmaceutical Industry.
- Knowledge of Quality requirements, cGMP ́s, ICH, CFR, EU, local or any other as applicable guidelines and ISO Standards as applicable
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
- Fluency in English is a requirement
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Product Lifecycle Specialist - Loures, Portugal - Hovione
Descrição
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:
** CVs in English only**
We are looking to recruit a Candidate:
