Reporting to the General Manager, The QC Director will be in charge of a team of 38, including the QC Manager, QC Operations Lead, team leads and analysts. The QC Director will ensure that the deliverables of each project are dealt with in the QC Department within the timeframes defined, with quality and according to cGMP. The QC Director will coordinate and ensure working conditions in the QC Department in such a way as to guarantee the fulfilment of all applicable regulations, and will promote a culture of demanding and continuous improvement standards. The QC Director will keep up-to-date on the latest technologies and assure that all personnel has suitable training to carry out their functions, propose new methodologies and objectives and the necessary investments and resources, energize the team to provide an outstanding service to partners; and formulate and promote the site vision, mission and culture.
- 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 an 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.
- University, or equivalent, degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or in similar Chemistry/Health Sciences fields.
- 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.
- Knowledge in Analytical Chemistry, Quality Control and transfer/validation of analytical methods and QC procedures. Training and experience in GMP and ICH guidelines;
- Worked for a minimum of 15 years, including 5 years team management in the Analytical Chemistry/Quality Control area.
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