Quality Systems Specialist

2 semanas atrás

Loures, Portugal Hovione Tempo inteiro

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:

- Advise Team Members on Quality or Regulatory systems and Tools and provide support in the what are the best courses of action;
- Provide support in the preparation of new procedures and/or policies according to the requirements applicable to the company business and strategy and propose changes to the existing procedures as applicable;
- Provide support in the preparation of Quality and/or Regulatory Systems and Tools related documentation and training;
- Provide support to audits/inspections (Internal and of Health Authorities) and participate in other Corporate key activities, such as Corporate Quality or Regulatory KPI’s, Corporate Quality or Regulatory Training, Quality and/or Regulatory Systems Management (e.g., Documentation Management System, CAPA, Change Control, analytical computerized systems fillings, customer support, etc.);
- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmacy or similar scientific field (mandatory);
- Requires educational and/or 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;
- 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.

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