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:
Site Quality Audit Technical Expert (M/F)
The Site Quality Systems Technical Expert will participate on the implementation and management of the Quality Systems and Quality Tools at the site level, promoting a rigorous and continuous improvement culture to ensure compliant sites. It needs to liaise with the Corporate QS Management and also with its peers at the site level.
- Promote the importance of a continuous improvement culture, mitigating any tendency for complexity;
- Participate in Site Quality Systems key activities, such as:
- Audits: support to audits & inspections to site; perform audits (internal and/or external);
- QS SOPs – responsibility for keeping it update, revising and issuing new ones as needed;
- Training Management – assuring training within Quality group is defined and have established owners (experts on the topic);
- QS review (events trends and root-causes analysis and evaluation and establishment of improvement plans, change control performance and metrics;
- To assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible or in which participates.
- Degree in Chemistry, Chemical Engineering, or equivalent degree in a scientific area;
- Experience of a minimum of 3 years in at least one operational areas: Quality Control, Quality Assurance, Manufacturing, R&D, Engineering;
- Good understanding and proficient application of Quality requirements, cGMP´s, ICH/CFR guidelines, ISO Standards and Industrial Safety;
- Procedure writing skills;
- Trainer skills;
- Proficient spoken and written English;
- Analytical skills, proactive and creative personality;
- Accuracy and responsibility;
- Good communication skills;
- Team working and multi-cultural approach ability;
- Self-confidence, independence and organization.
- 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.