About Hovione:
Hovione is an independent family-owned international group of companies. We set ourselves apart through 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 diverse team of over 1950 members from 36 nationalities is located across Asia, Europe and North America. This includes 4 production sites in Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland.
We strive for innovation and excellence in everything we do: for our clients, partners and patients. That's why we are In it for life.
Your Role:
You will be responsible for developing, implementing and ensuring compliance with Process Validation/Product Performance Qualification (PPQ) and Continued Process Verification (CPV) procedures using Risk Management tools.
* Develop and implement PPQ/CPV procedures.
* Oversee validation status of Hovione's products and improve activities.
* Ensure compliance with Product Lifecycle standards across all Hovione Sites.
* Improve Hovione's Quality System by incorporating new methodologies and technologies.
* Maintain open communication channels with Site QA teams.
* Keep the area up-to-date with PPQ/QRM and Cleaning guidelines.
Requirements:
We are looking for a candidate with:
* A University degree in Chemistry, Chemical Engineering, Pharmacy or a similar scientific field.
* 4+ years of experience in operational areas, preferably within the Pharmaceutical Industry.
* Knowledge of Quality requirements, cGMP, ICH, CFR, EU and ISO Standards.