Hovione is an international company with over 60 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 position of QC Director at our Cork site:
Reporting to the Site General Manager, in this role the successful person will be responsible for the QC and AS&T groups and will have QC Managers reporting in directly.
- To provide a safe place of work for all QC staff,
- To ensure safe work practices are utilised in all QC work activities,
- To ensure that QC project deliverables are met within the timeframes defined, with the required quality and according to cGMP;
- To coordinate and establish working conditions and behaviours in the QC Department in such a way as to guarantee the fulfilment of all applicable regulations;
- To promote a culture of continuous improvement;
- To Keep up-to-date on the latest technologies and to assure that all personnel has suitable training to carry out their functions;
- To propose new methodologies and objectives and the necessary investments and resources;
- To energize the team members to providing an outstanding service to our partners;
- To formulate, support and promote the site vision, mission and culture.
- Assure that the right analytical support is given in time to internal and external customers by planning the work to be carried out;
- Assure that the equipment available is used in a productive way;
- Assure training of all Human Resources in such a way to guarantee the best support to the Projects;
- Guarantee the fulfilment of all GMP requirements of the project teams as well as the Safety, Environmental and Health Regulations;
- Ensure the fulfilment of all tasks assigned in the Task distribution list of the Discipline;
- Meet the KPIs defined for the area
- Guarantee supervision of all analytical projects ensuring adequate technical execution, customer satisfaction and the achievement of the established objectives.
Job Dimensions Autonomy:
- To communicate with Clients as QC representative;
- Decide on the subjects of the training program;
- Define objectives and evaluate the direct reports;
- Define movements, promotions and salary levels of the members of the Department;
- Approve functional costs of the Department operations;
- Propose Current and Investment budgets;
- Propose head count;
- Approve test methods;
- Approve reports generated in the group;
- Close all non Critical Deviations generated in the group;
- Answer to Client and Health Authorities requests.
- Select and evaluate candidates for the Department;
- Define the methodology for the achievement of the tasks allocated to the Group;
- Evaluate the personnel performance and propose the corresponding career evolution;
- Monitor the training programe defined;
- Manage the responsibilities within the Department;
- Delegation within the Department;
- Define corrective actions and guarantee their application;
- Monitor the fulfillment of the applicable regulations;
- Verify the accomplishment of the objectives.
Job Main Activities:
- Planning and supervision of the activities within the Department;
- Propose and control the Exploration and Investment budgets;
- Evaluate the performance, training and career evolution of the Human Resources at least on a annual basis;
- Evaluate the needs of both the material and human resources;
- Ensure the information flow between the laboratory and the several internal and external customers;
- Assure that all the staff that works in the Laboratory is duly qualified;
- Represent the laboratory or nominate the laboratory delegates on meetings with clients, external and internal audits and for the Product/Project teams;
- Review and approve the analytical test methods to be executed in the laboratory;
- Review and approve the reports prepared in the QC Laboratory;
- Check and approve final product batches;
- Participation in both customer and regulatory audits on site;
- Communication with site general manager and other BU heads on all relevant information that impacts on the business.
- Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or in similar Chemistry / Health Sciences fields.
- Minimum of 8 -10 years in the analytical chemistry/Quality Control area.
- Sound Knowledge and understanding in Analytical Chemistry, Quality Control and transfer/validation of analytical methods and QC procedures.
- Training and experience in GMP and ICH guidelines;
Demonstrated experience in
- Leadership, Team Management and Communication skills;
- Good business sense;
- Result driven, team player, able to deal with multiple projects/tasks;
- Knowledge and Experience in GMP environment;
- Leadership and management skills;
- Experience in cGMP's and HSE rules;
- Practical experience within a Quality Control lab;
- Analytical skills and ability to make decisions under pressure.