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 Lumiar site:
Quality Systems Specialist (M/F)
This person will be responsible to working in a highly regulated cGMP environment, ensuring compliance to new and established quality system tools and metrics, global regulations and guidelines at a Corporate Level. To participate on the management of the Quality Systems and Quality Tools, promoting a rigorous and continuousimprovement culture to ensure compliant sites.
- To participate on Quality System Tools development, implementation and management for the company sites according to
the applicable requirements;
- To participate in Corporate Quality Systems key activities:
◦Quality System Tools;
◦Corporate Quality System KPI's;
◦Corporate Quality Training;
◦Quality Systems Management (Documentation management system, CAPA system, Change Control system,...),
Audits (Internal, External - Customers and Suppliers, Health Authorities);
- To participate on the Quality System performance management, contributing to its continuous improvement;
- To promote the importance of high quality levels and the importance of a continuous improvement culture in all core company activities;
- To 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
- Good understanding and proficient application of Quality requirements, cGMP´s, ICH/CFR, EU guidelines, ISO Standards and Industrial Safety;
- Experience of a minimum of 5 years in at least one operational area within Pharma/API industry (Quality Control, Quality Assurance, Manufacturing, R&D, Engineering...);
- Qualification on auditing is preferred;
- Good knowledge of IT applications (SAP, MS Office, LIMS, ...);
- Business sense;
- Analytical skills;
- Good communication skills;
- Proficient spoken and written English (fluent English level is a must);
- Team working ability;
- Multi-cultural approach ability;
- Sociable, critical, proactive and creative personality;
- Accuracy and responsibility;
- Self-confidence, independence and organization;
- Trainer skills;
- Responsibility, initiative and dynamism;
- Good Procedural writing skills.
- Full time opportunity;
- Remuneration and social benefits adjusted to the job function and matching the experience;
- Excellent workenvironment, with a strong focus on quality.