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Quality Assurance Manager
4 meses atrás
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:
- Manage and coordinate a Team of Quality Assurance Specialists, dedicated to Spray Drying Projects and Products;
- Provide technical support and expertise to solve operational issues with the Team and Clients (both internal and external);
- Manage the cGMP programs (e.g. validation, qualification, stability, environmental control), within the scope of the Team.
- Assure that products are released according to its quality and timing requirements;
- Streamline a continuous improvement culture, mitigating any tendency for complexity;
- Conduct regular inspections of the operational areas to verify compliance with cGMPs (e.g Internal Audits);
- Represent the QA function in clients and regulatory audits or inspections;
- Manage and evaluate regularly data regarding the Key performance indicators established for the area;
- Approve, on quality’s behalf, IOPs, change control documents and process related documentation;
- Evaluate/approve equipment cleaning, qualification protocols and reports;
- Coordinate the Team in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all team members are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
- Masters’ degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field;
- Typically requires 5 years of relevant experience within a Quality Assurance GMP environment within the Pharmaceutical Industry (mandatory);
- Previous experience (minimum 2 years) in operational areas such as Manufacturing, R&D or QC (mandatory); understanding of Spray Drying Process will be considered a plus;
- Experience in leading others and managing teams and/or Project Teams;
- Possess solid knowledge of Quality, cGMPs, ICH and ISO guidelines and practices;
- Knowledge of Regulatory Affairs;
- Good communication skills (verbal and written);
- Fluency in English is a requirement.
**Hovione is a proud Equal Opportunity Employer**
Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.
