Quality Assurance Technical Expert
Auto req ID: 170BR
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.
- 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.
- 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.