Hovione is an international company with over 55 years experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
To reinforce our team we are looking to fill the following position at our Loures site:
Quality Assurance Technical Expert
The QA Technical Expert will be responsible to guarantee cGMP compliance in all activities and systems related to the projects execution, according to Hovione Quality Policy, in quest of continuous improvement of the Quality System efficiency and effectiveness.
- Promote the importance of a continuous improvement culture, mitigating any tendency for complexity;
- Manage Quality Product key activities for the assigned products (Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Customer Complaints, Customer requirements, PQR) – e.g. approval of operational areas auxiliary documentation, preparation of quality related reports, reviewer of
- documentation generated by the operational areas;
- Contribute to the management of the quality system, namely participating in the documentation revision and update;
- Provide training to the operational areas in applicable cGMP and internal procedures;
- Assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible or in which participates.
- University degree in Chemistry, Chemical Engineering, Pharmacy or equivalent degree in a scientific area;
- 2 to 4 years’ experience in Operational areas (RD or Manufacturing);
- Availability to travel abroad to support project’s transfer or implementation;
- cGMP knowledge;
- Regulatory Affairs basic knowledge;
- English fluency (written and oral);
- Ability to stand and to discuss technical aspects with clients and suppliers.
- 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.